The following Poster Session from the 2012 AAD meeting in San Diego aimed to raise the profile of the use of sulphur as a treatment in rosacea. Did you know that Sulfur was first proposed as a treatment for rosacea in 1855 !

I wasn’t aware that sulphur was able to kill demodex mites, this is news to me. I do have to wonder, though, why such a common element, available as a demodex treatment since 1955, it was not tested when researchers published a list of How to Kill Demodex Mites. I would want to see further proof of this first.

Those interested in trying an easy to obtain topical sulphur treatment, have a look at Prosacea or even Rosacea-LTD. Prescription preparations worth looking at include: Clarifoam EF, Klaron and Rosanil. Plexion has been discontinued in early 2011.

An Underrated Treatment ?

I am impressed with how well Prosacea is liked. This cheap and easily available treatment seems to be well received, especially for the usual papules and pustules of rosacea. I was also a fan or the Sulfur based Rosacea-LTD as well.

This poster session is a good reminder to re-examine topical sulfur.

Poster Session 5503

Sulphur for rosacea: Are we reinventing the wheel?

American Academy of Dermatology 70th Annual Meeting, March 16–20, 2012, San Diego, California. Poster Abstracts, Supplement to JAAD, April 2012, Volume 66, Number 4.

Catherine McKay, MBBS, Skin and Cancer Foundation, Darlinghurst, Australia; Keiron Leslie, MD, Department of Dermatology, San Francisco, CA, United States; Leone Snowden, NSW Medicines Information Centre, Darlinghurst, Australia; Margot Whitfeld, MBBS, Department of Dermatology, Darlinghurst, CA, United States

Rosacea is a common, chronic inflammatory facial condition that affects approximately 13 million individuals in the United States alone. It has been a human affliction since time immemorial. Despite this, the pathogenesis remains largely unclear.

Cutaneous Demodex mites, altered vascular reactivity, alcohol ingestion, Helicobacter pylori, and Staphylococcus epidermidis have all been implicated.

The therapeutic armamentarium to treat rosacea is extensive, and some rosacea remedies date back to before the Middle Ages. Sulphur, as a treatment for cutaneous disease, was described in the Ebers Papyrus, an ancient Egyptian medical scroll, dated circa 1550 BC.

James Morris in Lancet describes the first effective sulphur containing formulation to treat rosacea in 1855. This was followed by a modification of the Danish formula, originally used to treat scabies, by Ayers and Ayers in 1932. This formulation contained 11% sublimed sulphur.

In the 1950s, 10% sulphur with 5% Peruvian balsam was used for Demodex-associated eruptions. Modern sulphur containing formulations for rosacea incorporate 10% sodium sulfacetamide combined with 5% sulphur. The new foam formulations are easier to apply and exude fewer odors.

Antiseptic, antibacterial, and antifungal properties have been attributed to sulphur. These antibacterial properties have been demonstrated against Propionibacterium acnes, some Streptococci, and Staphylococcus aureus.

Sulphur has also been shown to kill Demodex mites, which have been implicated as a possible causative factor in rosacea.

In recent times, sulphur has declined in popularity, largely because of its odor.

With the emergence of antibacterial resistance to other agents, as well as sensitivity to other topical antibiotics, topical sulphur has once again become a useful therapeutic option.

We have translated these older formulations into modern recipes that can be compounded today.

The aim of this poster is to remind the modern dermatologist of a safe, affordable and currently underused ‘‘remedy’’ for the treatment of an age old dermatologic condition.

Commercial support: None identified.

Related Articles

• Just How do you Kill Demodex Mites ?
• RSRP: Sulfur / Sodium Sulfacetamide Topicals
• Prosacea User Reviews
• Rosacea-LTD User Reviews
• Clarifoam EF good for Rosacea, Acne and Seborrheic Dermatitis

No searching could find a product from L’Oreal that contained the following ingredients;

• palmitoyl tripeptide-8
• epurea extract
• bisabolol
• caffeine
• zinc gluconate

So it would appear that this is a new product under development from L’Oreal. This is potentially very good news for rosacea sufferers.

If you find the name of this product please let us all know in the comments below.

Rosacea sufferers will be aware that Rosacea heavyweight Galderma started life in 1981 as a joint venture between L’Oreal and Nestle.

Poster Session 5554

Clinical evaluation of the effectiveness and tolerance of a facial lotion on subjects with rosacea

American Academy of Dermatology 70th Annual Meeting, March 16–20, 2012, San Diego, California. Poster Abstracts, Supplement to JAAD, April 2012, Volume 66, Number 4.

Susana Raab, L’Oreal Research and Innovation, Clark, NJ, United States; Christian Oresajo, L’Oreal Research and Innovation, Clark, NJ, United States; Margarita Yatskayer, L’Oreal Research and Innovation, Clark, NJ, United States; Zoe Draelos, MD, Duke University School of Medicine, Durham, NC, United States

Background: Rosacea is a chronic skin condition involving inflammation of the cheeks, nose, chin, and forehead. It causes redness, flushing, and inflammatory papules. Subjects with rosacea have sensitive skin that is easily irritated by skin care products. There is a need for a topical product that reduces the signs and symptoms of rosacea without exacerbating the disease.

Methods: This study evaluates a facial lotion formulated with palmitoyl tripeptide-8, epurea extract, bisabolol, caffeine and zinc gluconate, in female volunteers with mild to moderate facial rosacea and the presence of a minimum of three inflammatory papules.

This clinical study included 50 female subjects between the ages of 25 and 60 with evaluations at baseline, postapplication, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after product application.

For the duration of the study, volunteers used the facial lotion twice daily, and continued using any rosacea medications provided the type and dosage was stable for 3 months prior to study participation.

Evaluations were performed by a board-certified dermatologist and included objective and subjective tolerance grading, clinical efficacy grading of facial skin attributes for redness, flushing, smoothness, radiance, skin tone evenness, overall appearance, and rosacea severity using a 5-point ordinal scale.

Lesion counts, noninvasive bioinstrumentation to assess transepidermal water loss (TEWL), hydration and skin redness, subject self-assessment questionnaires, and digital photography were also included in the study.

Results: The results of this study showed significant improvements in redness, flushing, smoothness, radiance, overall appearance and
rosacea severity. The results showed a significant reduction in lesion count at all time points when compared to baseline.

There was a statistically significant drop in facial redness at week 4 and the TEWL measurements remained steady throughout the study demonstrating that the lotion is a gentle to the skin. Tolerance evaluations indicated the facial lotion was well tolerated by the study  panel.

Commercial support: 100% is sponsored by L’Oreal Research and Innovation.

Related Articles

• L’Oréal strong sales via Galderma and dermatology
• Exotic and Expensive Cosmetics, Do They Work ?

A recent press release teases rosacea sufferers that a topical foaming form of minocycline might become a new treatment.

The trial results promoted in the press release are for a condition called Impetigo, a bacterial skin infection.

Minocycline, as a member of the tetracycline family may offer some anti-inflammatory benefit to rosacea sufferers, but the question remains as to whether this benefit can be seen via a topical application. Minocycline is an unstable chemical and thus far has only been suitable as a systemic treatment – topical treatments have not been readily available.

Foamix Minocycline and Rosacea

We learnt in 2010 that a Phase II clinical trial was underway to examine whether a topical form of minocycline could help with rosacea. This trial NCT01134991 is due to complete in March 2012.

Foamix Impetigo Press Release

Foamix’s Minocycline Foam – 100% Effective in Impetigo Phase II Clinical Trial With No Side Effects – 80% Improved Significantly After 3 Days of Treatment

REHOVOT, Israel, March 14, 2012 /PRNewswire via COMTEX/ — Foamix, a clinical stage specialty pharmaceutical company, announced today the successful completion of the Phase II clinical trial of Minocycline foam in Impetigo patients. Minocycline Foam has shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA).

…

"These results are excellent; especially considering this study is the first to treat patients with topical Minocycline. The results confirm the efficacy of our Minocycline Foam in skin infections. It is also significant that our Minocycline Foam was well-tolerated and that there was no evidence of clinical safety concerns since one of the persistent barriers to the development of new classes of antibiotics has been the issue of patient safety," commented Dov Tamarkin, Foamix CEO. "We intend to aggressively pursue the development of our Minocycline Foam as a first-line treatment for a range of skin conditions, including Acne, Rosacea, Impetigo and other skin infections."

Key Features of Foamix’s Minocycline Foam

Minocycline is an extremely unstable compound, which currently exists only in oral dosage forms. Foamix successfully developed a stable, patient-friendly topical foam containing up to 4% Minocycline.

The topical administration of Minocycline Foam provides concentrated drug delivery to the infected lesion site, and leads to rapid cure, whilst avoiding the side effects common in the oral Minocycline treatment.

With a twice daily application, Minocycline Foam can lead to better patient compliance compared with other treatment options.

Foam is a user friendly dosage form which spreads evenly and absorbs easily without rubbing. This offers a great advantage when treating open wounds especially in small children.

Related Articles

• RSRP: Minocycline
• Foamix to Trial Foaming Topical Minocycline
• How do Tetracyclines Help Rosacea ?

In January 2009 we learnt that Medicis was interested in trialing Ziana as a treatment for rosacea. Medicis may be known to rosacea sufferers because they also make Plexion and Solodyn.

Sadly the rigorous nature of a clinical trial was not able to show that Ziana could reduce the papules and pustules of rosacea any better than the placebo.

Some Small Good News

The trial did find “nearly significant” (a hopeful term if I ever heard one) improvement in how the doctors perceived the broken blood vessels and also provable significant improvement in the redness associated with the rosacea symptoms.

Note also that participants experienced statistically significant increased facial scaling.

So overall not a great result for Medicis, whom I’m sure would have liked to been able to promote Ziana as an official treatment for the papules and pustules of rosacea.

User Reviews

Did you try Ziana ? Did you find any reduction in redness and facial blood vessels ? Would you recommend it ?

A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks.

J Drugs Dermatol. 2012 Mar 1;11(3):333-9.

Chang AL, Alora-Palli M, Lima XT, Chang TC, Cheng C, Chung CM, Amir O, Kimball AB.

Background: Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features.

Objective: To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage.

Methods: Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects’ validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage.

Results: There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10).

However, there was nearly significant improvement in physicians’ assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks.

The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug.

Conclusions: A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype.

Our preliminary study suggests that future studies with much larger sample size might confirm our findings.

Clinical Trials: NCT00823901.

Related Articles

• Medicis readies to trial Ziana for rosacea
• RSRP: Solodyn, Plexion

I thought this article from the Vancouver Sun was quite interesting from the point of view of developing new products for rosacea sufferers. Just how do you get from something that you think might work, to a product that all rosacea sufferers can use?

Clinical trials can take millions of dollars and dozens of years to get through the FDA, to become a new drug. Is there another option though?

This article tracks Vancouver dermatologist Jason Rivers who is attempting to develop and promote the Riversol range of products as being helpful for rosacea sufferers.

The Active Ingredient

The active ingredient present in Riversol is Beta-thujaplicin (β-thujaplicin, also known as Hinokitiol), an active that appears to have limited published research so far.

One paper is Inhibitory Effect of β-Thujaplicin on Ultraviolet B-Induced Apoptosis in Mouse Keratinocytes and perhaps another In Vitro Inhibitory Effects of Hinokitiol on Proliferation of Chlamydia trachomatis.

β-Thujaplicin is a molecule from the Western Red Cedar tree. You can hear Dr. Rivers discuss in this short YouTube video: Dr. Jason Rivers on Thujaplicin.

The Products

The Riversol for Rosacea, Normal to Dry Skin consists of 3 products, a cream cleanser, serum and moisturizer. The list of ingredients follows.

Cream Cleanser Ingredients

Aqua/Water, Mineral Oil, Propylene Glycol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Polysorbate 60, Polysorbate 80, Hinokitiol (Beta-Thujplicin), Allanloirl, Xanthan Gum, PVM/MA Decadlene Cross-Polymer, Benzophenone-4, Specially Denatured Alcohol. Phenoxyethanol, Methylparaben, lsopropylparaben, Isobutylparaben, Butylparaben, Sodium Hydroxide.

Serum Moisturizing Cream Ingredients

Aqua/Water, Mineral Oll, Propylene Glycol, Petrolatum, Cetearyl Alcohol. Polysorbale 60, Hinokitiol (Beta-Thujaplkin), Tocopheryl Acetate, L-Ascorbic Acid, Disodium Lauriminodipropionate Tocopheryl, Phosphates, Propylene Glycol Alginate (from sea kelp), Titanium Dioxide, Xanthan Gum, Specialiy Denatured Alcohol, Phenoxyethanol, Melhylparaben, lsopropylparaben, lsobulylparaben, Butylparaben, Tetrasodium EDTA.

Riversol for Rosacea Serum Ingredients

Aqua/Water, Propylene Glycol, Hinokitol (Beta-Thujplicin), Disodium Lauriminodipropoplonate Tocopheryl Phosphates. Aminopropryl Ascorbyl Phosphate, Propylene Glycol Alginate, Xanthan Gum. PVM/MA Decadiene Crosspolymer, Specially Denatured Alcohol, Phenornyethanol, Methylparaben, lsopropylparaben, lsobulylparaben, Butylparaben, Sodium Hydroxide, Terasodium EDT A, Benzophenone-4

Contrast the list of ingredients with for eg. Metrogel 1% which consists of just metronidazole in a base of betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water.

Cost

Are you sitting down?

The 3 products are available from their web site for a whopping $CAD 218.00, although a sample kit is also available.

From the Vancouver Sun;

Walking the fine line between marketing and medicine

Vancouver doctor’s company looking at ways to sell cream that treats rosacea

By Jenny Lee, Vancouver Sun June 8, 2011

You know that lovely, idle, workday dream? The one where you turn a great little work idea into a mega-business and retire to acclaim and fortune?

Vancouver dermatologist Jason Rivers is going for it.

It all started 10 long years ago when Rivers, a University of B.C. dermatology professor who is also in private practice, learned of an ingredient that seemed useful as an anti inflammatory, antifungal and anti-microbial.

Beta-thujaplicin (thoo-ya-PLY-sin) isn’t really cost-effective to extract or synthesize for use in most skin-care products, and clinical research on its efficacy is still limited.

But Rivers was intrigued, and when by chance he met a cosmetic chemist, he asked for a custom formulation of antiaging, sensitive-skin creams containing the ingredient. Rivers no longer remembers how much that cost, but it was a whole lot less than he expected. He handed jars out to friends and patients and colleagues for free. "I thought it was going to be a one-off flash in the pan," Rivers said, but people started asking for it.

…

"We’re simply saying it’s effective for sensitive skin," he said. "We’re not saying it will cure rosacea."

He’s insisting on providing free samples so consumers aren’t coerced.

"It’s not going to work for everybody. Some people may find it irritating to their skin. We’re just saying there’s an alternative for you."

And he’s careful with loaded words: "I never say ‘pure’, never ‘the best’, never ‘guaranteed.’" "Being an academic, I’m fairly skeptical by nature, so I haven’t given up my day job. I had a vision to do something and, at the very least, I’ve brought my vision to reality," Rivers said. "Where it goes, I don’t know.

Related Articles

• What is the Best Moisturizer for Rosacea ?
• Inactive Ingredients Just as Important as Active Ingredients
• 4% Quassia Amara Extract as good as Metrogel and Finacea

Recent research is highlighting just how important are all of the ingredients in a topical preparation.

The benefits to your skin from the vehicle components help explain why one might even obtain relief from vehicle-only preparations. For example if you are on a clinical trial that is blinded. Particularly if your skincare regime is not supporting the functions of your skin, the vehicle carrying the active ingredient in a topical may itself be worth using.

This further reinforces the argument that a gentle (and supportive) skincare regime is important for rosacea sufferers.

Of course mixing your own topicals is not an easy task, so mostly we are limited to the formulations that have been made for us by the pharmaceutical companies.

As a refresher here is a listing of ingredients of the most popular rosacea topicals. As you can see it is not an easy task to discover just from the listing whether a topical is going to be a winner for you.

Metrogel Ingredients

METROGEL (metronidazole gel), 1% is an aqueous gel; each gram contains 10 mg of metronidazole in a base of betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol,propylparaben and purified water.

Finacea Ingredients

Each gram of Finacea contains 0.15g (15%) micronized azelaic acid in a gel base. It also contains 0.1% benzoic acid, propylene glycol, polysorbate 80, lecithin, polyacrylic acid, triglycerides (medium chain), sodium hydroxide, disodium edetate and purified water.

Plexion Ingredients

Each gram of Plexion® (sodium sulfacetamide USP 10% and sulfur USP 5%) Topical Suspension contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a suspension containing: Purified Water USP, Propylene Glycol USP, Isopropyl Myristate NF, Light Mineral Oil NF, Polysorbate 60, Sorbitan Monostearate NF, Cetyl Alcohol NF, Hydrogenated Coco-Glycerides, Stearyl Alcohol NF, Fragrances, Benzyl Alcohol NF, Glyceryl Stearate (and) PEG-100 Stearate, Dimethicone NF, Zinc Ricinoleate, Xanthan Gum NF, Edetate Disodium USP, and Sodium Thiosulfate USP.

Klaron Ingredients

Each mL of Klaron (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.

Research Abstracts

Topical rosacea therapy: the importance of vehicles for efficacy, tolerability and compliance, J Drugs Dermatol. 2011 Jun 1;10(6):627-33, Jackson JM, Pelle M.

Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely.

These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target.

Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments.

Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be non irritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.

Further related research;

THE IMPORTANCE OF VEHICLE IN ACNE THERAPY

Emil A. Tanghetti, MD, Chair, A Supplement to Skin & Allergy News,

Skin Disease Education Foundation’s 29th Annual Hawaii Dermatology Seminar, a continuing medical education program, March 18-24, 2005, in Maui, Hawaii. 

Physicians attempting to balance aggressive acne treatment with tolerability stress the importance of restoring hydration of the stratum corneum. Research demonstrating the stratum corneum’s pivotal role in drug delivery has sparked renewed interest in this topic.

Many common conditions directly and indirectly affect barrier function.  For example, atopic dermatitis, psoriasis, and acne affect barrier function directly through the impact of the inflammatory process on epidermal growth and maturation. Medications used to treat a number of conditions indirectly disrupt barrier function.  Topical retinoids—the mainstay of acne treatment—change and disrupt barrier function.

Several signs and symptoms characterize damage to the epidermal barrier.  Dryness and peeling occur when the water content of the stratum corneum falls below 10%.  This creates a damaged and leaky epidermis that may lead to overabsorption of topical medications and products, causing even more barrier damage.

Summary

Restoring and maintaining barrier function is critical for outcomes in patients with dermatologic diseases.  For optimal hydration, a vehicle that is both occlusive and humectant is ideal.  The addition of moisturizers such as dimethicone and glycerin to acne treatment products helps maintain barrier function and will provide better outcomes. This is particularly important when topical retinoids are included in the therapeutic regimen. For comedonal acne, combination products containing moisturizers may be effective first-line agents. Finally, clinicians should consider the vehicle prior to prescribing or recommending any products to patients with acne.

Related Articles

• Metronidazole (Metrogel, Flagyl) is a popular rosacea treatment
• Finacea Gel (azelaic acid 15%) as a Rosacea Treatment
• RSRP: Sulfur / Sodium Sulfacetamide Topicals

A search on PubMed for Quassia extract reveals a a couple of dozen relatively recently published articles investigating the chemical makeup of Quassia extract, and its effect as an anti-ulcerogenic, as an antimalarial, and antibacterial and antifungal agent. It would seem from this that Quassia amara is attracting a growing interest as a pharmacological active.

Many drugs can trace their genesis to a biological source. Whilst a natural source for an interesting extract may sound enticing, even promising, I see the advantage of a natural source being the ease of sourcing experimental samples. The easier samples are to source, the more likely that researchers will be willing to undertake new studies.

It is tempting to get excited about something new, and the promise that it may bring to rosacea sufferers, but I like to caution my excitement with the knowledge that “nothing is as promising as an unproven treatment”.  That is, it is easy for a new treatment to hold some promise, but far harder for it to be proven to be more effective, less problematic and therefore superior to what we already have.

Having never heard of Quassia amara before today I look forward to reading more about it in the future.

Evaluation of the Efficacy and Tolerance of a Topical Gel With 4% Quassia Extract in the Treatment of Rosacea

J Clin Pharmacol. 2011 Feb 22, Ferrari A, Diehl C, Universidad Nacional de Córdoba.

Background: There are various treatment options available for rosacea, depending on the subtype, but treatment is still generally unsatisfactory. Some studies have reported antiparasitic and anti-inflammatory properties of Quassia amara.

Aim: To check the efficacy and safety of a topical gel with 4% Quassia amara extract in the treatment of various grades of rosacea.

Methods: A group of 30 patients with various grades of rosacea (I-IV) were investigated in a single-center, open-label study. They were treated with a topical gel with 4% Quassia amara extract for 6 weeks. Response was evaluated by the flushing, erythema, telangiectasia, papules, and pustules scores. At the end of therapy, overall improvement, safety, and tolerability were assessed.

Results: Twenty-seven of 30 patients (90%) completed the study. The treatment resulted to be very effective, and the results achieved were in line with those published with topical metronidazole and azelaic acid. Safety and tolerability were excellent.

Conclusion: Topical quassia extract could be a new, efficient, and safe weapon in the armamentarium for the management of rosacea.

Related Articles

• The Top Natural Rosacea Treatments
• Lavender, arnica, aloe vera, tea tree oil, and calendula ; do they work ?
• Green Tea Extract may benefit rosacea
• hardy kiwi fruit extract may help atopic dermatitis
• Silymarin (Milk Thistle) + MSM, User Reviews

Trolling patent applications is pretty turgid work. Mostly patents seem to be intellectuals marking out their claims in the hope that future products might result from their discoveries.

This patent application starts badly with firstly spelling Rosacea incorrectly as Rosascea. Pretty embarrassing Allergan ! To save you from seeing this misspelling again I’ll spell it correctly in the extract below.

Sometimes you find interesting information at the bottom of patent applications – where applicants sometimes provide proof that their invention works. In this patent application we find claims that Dapsone is as good as Finacea, Oracea, Metrogel 1% at reducing the facial lesions associated with rosacea.

Allergan, the makers of Aczone, are listed as the owner of this patent.

Back in June 2008 I wondered if Allergan buying Aczone, meant that they had plans for rosacea targeting. In August 2009 Allergan was warned by the FDA for overstating the efficacy and underplaying the risks of Aczone.

Patent Application 20100310480

DAPSONE TO TREAT ROSACEA

The methods described herein provide treatment of rosacea using topical formulations of dapsone. The methods also provide treatment of rosacea with topical dapsone in combination with other active agents, including metronidazole. The methods avoid negative hematologic side effects, including hemolysis and hemolytic anemia, that are associated with oral administration of dapsone.

[0007] In a preferred embodiment, the pharmaceutical composition is a semisolid aqueous gel. The semisolid aqueous gel includes a thickening agent, water, a solvent, preservative, microparticulate dapsone, dissolved dapsone, and caustic material. In a preferred embodiment, the caustic material is a base agent. In a preferred embodiment, the composition exhibits an optimal balance between dissolved dapsone that is available to cross through the stratum corneum of the epidermis and be absorbed into the lower two-thirds of the pilosebaceous unit; and microparticulate dapsone that is retained in or above the stratum corneum to serve as a reservoir or to provide dapsone to the supracorneum zone, crossing the stratum corneum of the epidermis only minimally as a solid. The solid microparticulate dapsone reservoir is slowly dissolved in body fluids before it is delivered through the stratum corneum

[0048] Currently, use of oral dapsone is generally limited, as its use may be associated with hematologic side effects, including hemolysis and hemolytic anemia that are dose-dependent and occur more frequently with increasing dose (Zhu and Stiller 2001; Jollow et al., 1995). The mechanism of dapsone-related hemolysis and hemolytic anemia involves oxidative damage to red blood cells and is associated with the dapsone hydroxylamine metabolite (Prendiville et al., 1988).

[0109] A review of historical results for other approved therapies shows that the mean changes from baseline in lesion count for the dapsone 2 timesa day group was close to that of other approved products for rosacea, including Finacea,(azelaic acid) Gel, 15%, Oracea  (doxycycline) 40 mg capsules, and the active comparator in this study, MetroGel (metronidazole), 1.0%.

See the Aczone Prescribing Information for the official list of indications, contraindications and known side effects for this treatment. The official web site for Aczone is at aczone.com. According to Allergan, women fare better on Aczone. See the Efficacy page for examples of the sorts of improvements that you might expect from Aczone after 12 weeks use.

Related Articles

• Allergan buys Aczone, has plans for rosacea targeting ?
• Aczone Gel (5% Dapsone) gets FDA approval for Acne
• FDA gets tough with Allergan over Aczone

A new story by Mike Armstrong in the Philadelphia Enquirer tells us that the company behind Omiganan, a new treatment targeted at rosacea, has just 2 employees.

Described as a “Development-stage dermatology products maker” and “a virtual company that in-licenses compounds from other companies”, Cutanea shows that small startup-scale companies can at least gain momentum in the dermatology development market.

One way that small dermatology companies can grow is to go public. Cutanea believe that their topical cationic peptide Omiganan forms part of a compelling product portfolio, worth forming a public listed company around.

Cutanea seeks to be 3rd Philly-area life-sciences IPO of 2010

According to a prospectus filed with the Securities and Exchange Commission, it has just two employees – president and chief executive officer Robert Bitterman and Kimberley Forbes-McKean, its chief scientific officer.

Cutanea hopes to raise $13 million from an IPO and use about $4 million to fund a Phase III study of a treatment for rosacea, an inflammatory skin condition characterized by redness in the face.

Rosacea News featured Omiganan in this recently list of What’s Hot in New Rosacea Treatments. Cutanea is seeking to raise $13m, partly in order to complete trials for Omiganan.

Further details from the SEC Filing for the IPO include:

• Cutanea suggest that Omiganan is superior to Metrogel and Finacea because as well as being able to clear the papules and pustules of rosacea, it also is effective against the “secondary signs and symptoms of rosacea including peeling, dryness, itching, burning and erythema (redness).” Thus the primary endpoint for the phase III trial will be for the inflammatory lesions of rosacea and the secondary endpoint being the so-called secondary signs.
• Omigana has been tested as a once daily 2.5% gel.
• The phase III trial is expected to commence in mid-2011 and involve 600 participants using either Omiganan or placebo for 12 weeks.
• All things going well the development process hopes to file a New Drug Application in 2013.
• Cutanea also plan to target atopic dermatitis with Omiganan.
• Cutanea has licensed the exclusive worldwide rights for dermatological uses to omiganan from Biowest Therapeutics Inc.

[update:] November 15, 2010. We have been told that Cutanea has postponed the IPO for a second time.

Related Articles

• Cutanea Life Sciences files IPO to fund Omiganan development
• Omiganan (topical cationic peptide) to be trialled as rosacea treatment

This just published paper details a `new’ product that comprises a slight twist on an old formula. It seems that much of modern research and development involves tweaking existing treatments to see how their efficacy and product lifecycle can be extended.

This new product is known as CLARIFOAM EF Emollient Foam, and is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. The company web site boldly claims that Clarifoam EF effectively treats all 3 conditions.

In combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes thereby reducing the inflammation associated with acne.

The active ingredients of Clarifoam EF are a combination of 10% sodium sulfacetamide and 5% sulfur.

The Clarifoam Prescribing Information mentions two forms of application: The Wash-Off application and the Leave-On application. The Wash-Off application suggests a 10 minute application 1-3 times a day to clean dry skin and rinsing thoroughly with water. The Leave-On application suggests the same 1-3 times a day, but wiping off any excess and otherwise leaving the foam application untouched.

The product comes in an aluminium can which needs to be primed before its first use and shaken vigorously before each use. A Clarifoam Rebate Coupon of up to $30 is available until the end of December 2010.

Here is the abstract of the study suggesting that Clarifoam is useful in treat the 3 conditions at once.

Dr. Draelos is well known to rosacea sufferers being on the expert panel that recently published the Standard Rosacea Management Options, the Cetaphil Cleansing Bar and Cetaphil Gentle Skin Cleanser, Clarisonic as well as cleansing and the management of rosacea.

The multifunctionality of 10% sodium sulfacetamide, 5% sulfur emollient foam in the treatment of inflammatory facial dermatoses. J Drugs Dermatol. 2010 Mar;9(3):234-6., Draelos ZD.

Prior to 1962, some of the most versatile drugs in dermatology were approved by the U.S. Food and Drug Administration (FDA) solely on the basis of safety.

One of these is the combination 10% sodium sulfacetamide and 5% sulfur. Sodium sulfacetamide possesses anti-inflammatory and antibacterial properties while sulfur is a nonspecific antibacterial and antifungal. A new emollient foam formulation of 10% sodium sulfacetamide and 5% sulfur allows a thinner application film and leaves behind no residue on hair bearing or non-hair bearing skin. The sulfur smell is also more quickly dissipated with reduced irritation.

This uncontrolled, observational, prospective, open-label, single site, eight-week study enrolled 24 subjects (eight with rosacea, eight with seborrheic dermatitis, eight with acne vulgaris) to evaluate the safety and efficacy of this novel foam formulation.

At eight weeks, statistically significant improvement was seen in inflammatory rosacea lesion counts and the signs of seborrheic dermatitis. A 50% reduction was noted in the total acne lesion counts. These findings confirm the versatility of an emollient 10% sodium sulfacetamide and 5% sulfur foam.

Clarifoam EF is made by Onset Therapeutics which is a subsidary of Collegium Pharmaceutical.

Other products that also feature a combination of Sodium Sulfacetamide and Sulfur include: Clenia, Rosaderm, Plexion, Ovace, Klaron, Rosanil, Rosac and Rosula. Yes indeed there is a lot of products you can choose should you wish to try out a formulation of these two actives.

User Reviews

1. Nora in the thread Clarifoam at the Rosacea Support Community;… However, he gave me a sample of Clarifoam and I used it for about 4 days. It made my skin so dry and chapped it was painful. I tried rinsing it off after application as the website says, but that didn’t help. I stopped using it and had to use Aquaphor for a few days to lubricate my skin. So, I guess this is not for me!!
2. harrysinghnyc in the thread Clarifoam at the Rosacea Form;I have tried pro-topic, metrogel and locoid lipocream and none could remedy my seb derm but today is the 2nd day I have applied clarifoam and i notice that the outbreak is 90% gone! I have never had this type of turnaround this fast! One day after using it, i am prescribed this foam lotion 2x daily, so this is awesome!
3. rf11 in the thread My rosacea is gone!! at the Rosacea Forum;Anyway, to update, I have been using clarifoam and Cerave soap for almost a month now, and my skin looks better than it has in years.
4. J-Mill in the thread clarifoam ef at the Rosacea Forum;I have tried this stuff recently and really like it. … In short, both medications attack some key Rosacea/Seb Derm aggravators. What I like about Clarifoam is I find the base really non-irritating, unlike most topicals I have tried. Everyone is different though and as always you should test patch topicals, especially one with sulfacetamide as some peopl are very allergic to it.
5. fyd in the the thread Clarifoam EF is the greatest! at the acne.org message board;… on Christmas eve my derm prescribed me with this stuff. He said that they were making my face look much more worse than it was and he was absolutely right. This product just came out about a month ago, so it’s brand new. I started using it on Christmas and in about a week and a half to 2 weeks, i saw a big difference. They were fading away, I couldnt believe it! To be honest, i couldnt stop smiling at what my face looked like. Now, they are very much still there, but very faint and they are starting to blend in very nicely. They are more of a light brown then red now. Ziana and Clarifoam are working great together.
6. [new] Barley says I was recently diagnosed with rosacea and my primary care doctor perscribed metrogel for me. I tried it, but it didn’t work well-plus it dried out my skin. So I then decided to see a regular dermatologist. The dermatologist recommended Clarifoam EF topically and Oracea orally. Clarifoam EFis a sulfur based topical treatment that I (thought) would be harmless. They had some free samples of the Clarifoam so I thought I’d try that before getting a perscription filled.Big mistake! Only after two days, I reacted horribly to it- My face broke out with blotchy pimples, is very red, texture is bloated and it’s very itchy! It was worse than the rosacea I was being treated for! I am now going to buy some cortizone cream to calm it down…but boy, am I glad I didn’t get that perscription filled! Also, I haven’t as yet started the Oracea pills yet. I wanted to wait till my face calmed down a bit.

Related Articles

• Product Page: Clarifoam EF
• RSRP: Sulfur / Sodium Sulfacetamide Topicals