Good News for Accutane Users

This growing body of proof is actually quite important because oral isotretinoin is not officially approved as a treatment for rosacea. Doctors can prescribe accutane off-label for use in rosacea, so more comprehensive trials of accutane can only be a good thing. Further, the growing difficulty in finding a doctor who will actually prescribe accutane means that rosacea sufferers need all the proof that they can get their hands on.

My Take

The paper referenced below was highlighted last year as Doxycycline is as good as Low Dose Accutane (0.3mg/kg/day). It is worth repeating that even though doses of around 20mg a day of accutane compared favourably to 100/50mg of doxycycline, the two drugs have quite different safety profiles. The advice of your doctor is going to be important here.

Rosacea : Systemic therapy with retinoids

Hautarzt. 2011 Oct 22, Thielitz A, Gollnick H, Universitätsklinik für Dermatologie und Venerologie , Otto-von-Guericke Universität, Leipziger Str. 44, 39120, Magdeburg, Deutschland

[Article in German]

Systemic isotretinoin has been known for decades as an effective and safe therapeutic option in the treatment of severe and refractory forms of rosacea. It can also be used in special treatment-resistant forms of rosacea, e. g. granulomatous rosacea, as efficacious second-line therapy.

Previously, the effect of isotretinoin in rosacea has been mainly studied in small cohorts or anecdotal reports.

Recently, a big randomized double-blind dose-response and comparative study revealed that an optimized dosage of 0,3 mg/kg was superior to other dosages and non-inferior to doxycycline as gold standard of systemic rosacea treatment and proved effective and safe in papulopustular and phymatous subtypes.

However, the substance is still not licensed for this indication The efficacy of isotretinoin in rosacea is probably mainly related to anti-inflammatory mechanisms as well as anti-oxidative, anti-angiogenic and antifibrotic properties. The classical antiseborrheic effect of isotretinoin might play a role in special subtypes like the phymatous type or rosacea fulminans.

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Over at the Acne Blog, Daniel Kern has posted a few high level posts relating to recent readings he has undertaken on the topic of diet and acne. Daniel has read the latest published research to see what new trends are emerging.

It is encouraging to see that research is continuing in this area. Long gone are the days when my dermatologist told me that diet had absolutely nothing to do with skin and suggested I could eat whatever I wanted in whatever quantities I wanted and I would suffer no change in my skin.

Diet and Acne: Wrapping it up

The last few days I have spent going through all clinical studies/trials regarding acne and Omega-3 fats, iodine, antioxidants, chocolate, calorie intake, fatty/oily food, digestion, and zinc.

Adding to this what I have learned regarding dairy and glycemic load, I’m sorry to say that nothing stands out for me as a smoking gun when it comes to diet and acne.

We simply don’t have enough research yet, and nothing feels super compelling to me at this point. However, at least researchers are looking into how diet may affect acne, so hopefully by the next time I review the literature, the evidence available to the scientific community will start taking shape. In the meantime, based on digesting everything the research community has to offer regarding diet and acne, here is what I am personally going to do as far as diet goes:

Dan goes on to offer some advice about what he will personally be doing as far as his diet is concerned; keep taking fish oil, keep eating wild seafood, a zinc supplement of 30mg a day, be eat generally healthily and not worry too much about iodine or chocolate for fatty foods.

Latest Greatest Research: Glycemic Load and Acne

If you eat a high glycemic diet with foods like white bread, sugary soda, white potatoes, and white rice, you will experience insulin spikes. This we know. What we don’t know (sorry Josh) is whether this sort of diet will directly affect acne.

Scientists hypothesize that a high glycemic diet and its resulting insulin reaction will result in higher levels of hormones (IGF-1 and androgens) which may contribute to clogged pores and increased skin oil production.

When it comes to high glycemic diets in particular, scientists also postulate that eating this way may lower the amount of beneficial proteins (IGFBP-3) and natural retinoids, which help keep skin cell growth in check and pores from becoming clogged.

However, as is becoming customary in my research on diet and acne, we do not have enough research to make any strong correlations.

Sadly, as is the case with much research, good thorough studies that will satisfactorily prove or disprove a link are hard to come by. The holy grail here will be to prove that permanently reducing your glycemic load lead to a permanent reduction in acne symptoms. Now that is something I would like to see.

Of course there are many many health benefits from eating a low glycemic diet, so you really can’t lose by trying this out yourself.

Latest Greatest Research: Dairy and Acne

Hormones: Milk contains hormones such as IGF-1 (insulin-like growth factor) and androgen (male hormone) precursors.

Iodine: Milk often contains iodine, largely due to farmers dipping the teats of cows in an iodine solution before milking in order to sterilize. At large doses, iodine can cause what are called acneiform eruptions. Acneiform eruptions look similar to run-of-the-mill acne vulgaris but are different in important ways.

….

What stands out strongly now that I have read all of the evidence is that the design limitations in dairy and acne studies thus far leave us without any concrete answers. After performing a thorough review of existing evidence, authors in the Journal of Clinics in Dermatology agree: “Our conclusion, on the basis of the existing evidence, is that the association between dietary dairy intake and the pathogenesis of acne is slim.”

Although the inflammation associated with acne and that linked to rosacea may not be directly related, I think all this sort of research is important for rosacea sufferers as more is discovered about how what we eat controls so many functions in our body.

Are You Convinced?

Surely there is no argument that a low glycemic diet is good for everyone, good for general health and a good step for your skin. Beyond that, do you believe that there is a causative link between diet and rosacea

How strong would research need to be for you to totally change your diet, if it could be proven that your rosacea is related to what you eat ?

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In contrast to the ongoing disputes over generic Oracea, the makers of the low-dose minocycline Solodyn, Medicis have entered into a joint development and sales agreement with Lupin Pharmaceuticals.

Solodyn is a form of Minocycline, a member of the tetracycline famaily, available in 8 strengths, prescribed based primarily on your weight.

Solodyn tablets are available in 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg.

Officially, Soldyn is indicated to treat the inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Medicis are known to rosacea sufferers as the manufacturers of Ziana and Plexion.

The Agreement

This agreement allows Medicis and Lupin to set aside the legal wrangling over the patents that are said to protect Solodyn, and allow Lupin to progressively manufacture Generic Solodyn. Additionally the two companies will work together to further develop the market for generic versions of Solodyn.

Lupin vs. Galderma

We also know from other court filings that Lupin Pharmaceuticals, along with Mylan and Impax Laboratories are all fighting for the right to manufacture Generic Oracea. Galderma is engaged in an extended dispute, using the Oracea Patents to attempt to stop others from manufacturing a cheaper version of Oracea.

This is Good News

This sort of agreement is good news for those who would like access to Solodyn, but at a more affordable price.

Rosacea Sufferers can only hope that Galderma would consider a similar agreement over Oracea. Too much to expect? Maybe so.

Medicis and Lupin Settle Solodyn Infringement Dispute; Agree to Drug Development Collaboration

Medicis has entered into multiple agreements with Lupin over the acne drug Solodyn, allowing the generic drugmaker to enter the market prior to the expiration of Medicis’ patents.

In a separate agreement, Medicis agreed to join Lupin in a drug development collaboration worth an initial $20 million to the generic company.

Medicis claimed Lupin infringed U.S. Patent Nos. 5,908,838 and 7,790,705 by seeking to manufacture a generic version of Solodyn before the patents expire.  The ’838 patent covers a slow-dissolving form of tetracycline, a class of oral antibiotics commonly used to treat acne.  When tetracycline dissolves too rapidly after being swallowed, the incidence and severity of side effects such as vertigo, dizziness, and blurred vision can increase.  The ’705 patent relates to methods of administering the dosages.

On July 21, Judge J. Frederick Motz signed off on a consent judgment that permanently enjoined Lupin from selling generic Solodyn except under the terms of a separate licensing agreement.  The licensing agreement allows Lupin to sell a generic version of Solodyn in various different doses prior to the expiration of the patents.  Under the agreement, Lupin can move ahead with 45mg, 90mg, and 135-milligram doses in November, the 65mg and 115milligram doses in February 2018, and the 55mg, 80mg, and 105milligram doses in February 2019. 

Under certain conditions that were not disclosed, Lupin could begin making the generic earlier.

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• Community Forum: Solodyn
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acne.org is a large online community of acne suffers that includes a small area for rosacea sufferers. The site is run mostly by volunteers and doesn’t accept any advertising. This in itself is something uncommon, a large internet site that isn’t owned by a commercial interest that doesn’t accept advertising. The site tells us that it uses the sales of their custom products to help pay for the running of the site.

The acne.org Regime

The regime has been developed by Mr. Kern as he was unhappy with the formulation, availability and cost of commercially available regimes for acne. Certainly the products that have been developed are generously sized and very cheap.

I applaud Mr. Kern and acne.org for developing their own treatment regime. Well done!

The acne.org regime consists of a Cleanser, a 2.5% Benzoyl Peroxide based Treatment Gel, Moisturizer with Licochalcone, Jojoba Oil and also a 10% Glycolic Acid based AHA+ product.

Even though the regime includes a benzoyl peroxide gel and a Glycolic Acid product, I thought that 3 other components; the cleanser, moisturizer and jojoba oil were worth highlighting.

If you are looking for a  cheap and simple cleansing and moisturizing regime, with a very short list of ingredients, then read on.

Acne.org Cleanser

Here is their description of the cleanser: “Liquid cleansers are less drying and can more easily achieve pH balance. However, liquid cleansers never lathered enough for me. I like a nice lather with my cleanser. So I asked several manufacturers for the impossible–a pH neutral liquid cleanser that lathers well. After trying 11 or 12 samples, the winning manufacturer came through with a carefully combined ingredient list which achieved an exact pH of 5.5. Since the pH of human skin is about 5.5, the result is a cleanser that leaves the skin in an even harmony without over drying or stripping the skin. And it lathers well! I was thrilled. I also made sure there were no perfumes or dyes. If you’re looking for a colored or scented cleanser, this is not the one for you. Instead, it is as simple as possible–a neutral pH, a nice substantial feeling in the palm, a gratifying lather, and a clean rinse.”

Cleanser Ingredients

Water, PEG-80 Sorbitan Laurate, Cocamidopropyl Betaine, Sodium Trideceth Sulfate, Glycerin, Sodium Lauroamphoacetate, PEG-150 Distearate, Sodium Laureth 13 Carboxylate, Disodium Cocamphodiacetate, Butylene Glycol, Sage Extract, Cucumber Extract, White Oak Bark Extract, Panthenol, Allantoin, Acrylates Copolymer, Methylgluceth-20, Polysorbate-20, Quaternium-15, DMDM Hydantoin, Disodium EDTA.

Read some honest reviews in the review area: Acne.org Cleanser

Purchase Cleanser at danielkern.com: $7 for 8 oz (235ml) or $9.50 for 16 oz (475ml).

Acne.org Moisturizer

The acne.org moisturizer contains Licochalcone, the same active ingredient promoted by the Eucerin Redness Relief range who claim that their products are proven to provide redness relief.

“Generously sized moisturizer with licochalcone. Also contains jojoba oil. Intensely hydrating, non-comedogenic lotion designed to eliminate dry, flaky skin. Goes on clear and absorbs quickly, leaving no residue. Super light feel, fragrance free and dye free.”

Moisturizer Ingredients

Water, Simmondsia chinensis (Jojoba) Seed Oil, Methyl Gluceth-20, Squalane, Saccharide Isomerate, Butylene Glycol, Sodium Hyaluronate, Glycyrrhiza glabra (Licorice) Root Extract, Panthenol, Tocopheryl Acetate, Cetearyl Alcohol, Sorbitan Olivate, Cetearyl Olivate, PEG-12 Glyceryl Distearate, PEG-23 Glyceryl Distearate, Carbomer, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin

Great to see Jojoba Oil being used here and the use of Licochalcone is also interesting.

Read some honest reviews in the review area: Acne.org Moisturizer, Dan’s New Formula

Purchase the Moisturizer at danielkern.com: $14.92 for 8 oz (235ml) or $24.19 for 16oz (475ml).

Acne.org Jojoba Oil

Great to see that our fellow skin sufferees (is that a word?) also love jojoba oil. For very dry skin this is great. Apply a few drops to your palms and gently rub into very wet skin. The oil absorbs really easily allowing you to further apply a moisturizer if required. I used to use vita oil when my skin was really dry and would recommend it to kick start your regime.

“Generously sized 8 oz. certified organic jojoba oil. I recommend people try a few drops of jojoba oil in whichever moisturizer they are currently using. It will not clog pores at all. Quite the contrary, it makes my skin look great and keeps my skin’s oil balanced. “

Jojoba Oil Ingredients

Jojoba Oil (100% Organic)

Read some honest reviews in the review area: Acne.org Jojoba Oil

Purchase Jojoba Oil at danielkern.com: $14.75 for 8oz (235ml).

Love To Hear From You!

I was excited to find that such a simple, elegant and inexpensive cleanser and moisturizer was easily available.

I’m quietly hopeful that these products might also become popular with rosacea sufferers. It would be a great result if rosacea sufferers were able to find here a gentler, simpler and cheaper regime that they thought possible.

Please let us know if you decide to give them a try.

Featured Products

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Even though this press release relates to Acne, it is still interesting to see companies searching for the next killer acne treatment. Whilst only some acne treatments are successful as rosacea treatments, we can still hope that this sort of research may lead to new treatments that are gentle and effective for rosacea sufferers as well. Certainly there is need for a treatment for severe acne to replace the maligned accutane.

Medicis is known to rosacea sufferers for making the medicated cleanser Plexion and the slow release minocycline Solodyn. Recently Medicis have announced that they are also trialing Ziana Gel (clindamycin phosphate 1.2% and tretinoin 0.025%) as a rosacea treatment.

Anacor and Medicis Enter Into Research and Development Collaboration for the Treatment of Acne

February 10, 2011

PALO ALTO, Calif. & SCOTTSDALE, Ariz.–(BUSINESS WIRE)– Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) and Medicis Pharmaceutical Corporation (NYSE:MRX) today announced that the two companies have entered into a research and development agreement to discover and develop boron-based small molecule compounds directed against a target for the potential treatment of acne.

…

Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovered five clinical compounds which are currently in development, including its three lead programs:

• AN2690, a topical antifungal for the treatment of onychomycosis;
• AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of psoriasis; and
• GSK 2251052, or GSK ‘052 (formerly referred to as AN3365), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which has been licensed to GlaxoSmithKline under the companies’ research and development agreement.

In addition, Anacor is developing

• AN2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections, and
• AN2898 as a topical anti-inflammatory product candidate for the treatment of psoriasis and atopic dermatitis.

For some background see; A Novel Borinic Acid Ester with Antibacterial Activity Against Propionibacterium acnes, an AAD Poster Session handout from 2006 referring to AN0128;

AN0128 (3-hydroxypyridine-2-carbonyloxy-bis(3-chloro-4-methylphenyl)-borane) is a novel compound that contains a boron atom within a borinic acid complex. AN0128 has broad spectrum activity against a wide variety of Gram positive bacteria, including many that are known skin colonizers.  Of particular and its causal role in acne vulgaris. 

The rise in antibiotic  P. acnes importance is to standard antibiotics necessitates the development of new P. acnes resistance of treatment agents.

AN0128 is a good candidate for a topical antibiotic and is currently being developed by Anacor as a novel therapeutic for acne and atopic dermatitis.

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Have read of this comic. Lets talk after you finish reading it.

xkcd: Significant

So what is all this about then ?

You mean what apart from highlighting how news articles cherry pick research findings and just confuse us to get a headline?

Often you see things like (p < 0.05) in a journal abstract. What does that mean? Well it is based on probability theory and relates to the confidence of one thing causing another.

What is a P-value?

The “P-value” is a measure of how likely something is to occur compared to just pure chance. For us who read medical abstracts, often we seem them used in statements like “Treatment X Significantly Reduced Symptom Y (p<0.05)”.

Here the value 0.05 means the probability that the result is related to pure chance is less than 5/100 or 5%.

This says that there was a strongly significant link between using Treatment X and seeing your Symptom Y reduced. The element of chance has been mostly eliminated as contributing to the result.

Once chance has been reduced to less than 5% researchers can say that there is strong significance in the results. This is the best result for a researcher looking for a new treatment; being able to use statistics to prove their treatment actually works.

The Punch Line

By the way, the punch line from the comic, visible if you hover over the graphic was “So, uh, we did the green study again and got no link. It was probably a “RESEARCH CONFLICTED ON GREEN JELLY BEAN/ACNE LINK; MORE STUDY RECOMMENDED!”

So there you go, our comic researcher just made a mistake

Want to ask a Question?

Statistics and probability theory can be quite complicated. Is there something you always wanted to ask about this topic? Leave it in the comments below and I’ll do my best to answer it.

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Being a teenager can be tough. Being a teenager with bad skin and good mental health can be even tougher.

If this study bears out in the larger population, then it is worth knowing that acne alone can be responsible for teenagers, most especially boys, thinking about suicide.

Suicidal Ideation, Mental Health Problems, and Social Impairment Are Increased in Adolescents with Acne: A Population-Based Study

Journal of Investigative Dermatology (2011) 131, 363–370;

Jon A Halvorsen, Robert S Stern, Florence Dalgard, Magne Thoresen, Espen Bjertness and Lars Lien

We performed a cross-sectional, questionnaire-based study to explore the relationship of suicidal ideation, mental health problems, and social functioning to acne severity among adolescents aged 18–19 years. A total of 4,744 youth were invited and 3,775 (80%) participated. In all, 14%reported having substantial acne (a lot and very much). Among those with very much acne, as compared those with no/little acne, suicidal ideation was twice as frequently reported among girls (25.5 vs. 11.9%) and three times more frequently reported among boys (22.6 vs. 6.3%). Suicidal ideation remained significantly associated with substantial acne (odds ratio 1.80, 95% confidence interval 1.30–2.50) in a multivariate model including adjustments of symptoms of depression, ethnicity, and family income. Mental health problems, as assessed by the Strengths and Difficulties Questionnaire (2.25, 1.69–3.00), low attachment to friends (1.52, 1.21–1.91), not thriving at school (1.41, 1.12–1.78), never having had a romantic relationship (1.35, 1.05–1.70), and never having had sexual intercourse (1.51, 1.21–1.89) were all associated with substantial acne in a multivariate model. Acne is frequently found in late adolescence and is associated with social and psychological problems. Adverse events including suicidal ideation and depression that have been associated with therapies for acne may reflect the burden of substantial acne rather than the effects of medication.

…

In this study, we could not directly address the claim that isotretinoin intake increases suicidal ideation and depression.

..

Although psychiatric difficulties are the main risk factor for suicide (Bridge et al., 2006), lack of attachment to friends and family is also associated with increased suicide risk (de Jong, 1992; Ledgerwood, 1999). In our study, the separate introduction of social variables (relation with family and friends, thriving at school, bullying, and experience with romantic relationships and sexual intercourse) in the multivariate model did not change the association between acne and suicidal ideation. As such relationships are important for many adolescents, these findings further strengthen our suggestion that acne is an independent risk factor for suicidal ideation.

…

Our study demonstrates and quantifies the association of reported acne to increased risk of suicidal ideation, mental health problems, and social impairment in a large population-based sample. Acne may influence life in a large number of adolescents in the community, as seen in the percentage of increase, even though the relative increase reflected in the Odds Ratios is quite modest. Especially relevant is the 80% higher level of suicidal ideation in adolescents with substantial acne than among those with no/little acne, independent of symptoms of depression, ethnicity, and family income in this population with low use of isotretinoin. Our results are helpful for clinicians, as subjective complaints are important when choosing treatment. Furthermore, these findings have public health implications because they underscore the need of appropriate health care for adolescent boys and girls in the community.

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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

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This is an unusual (or novel, depending on your viewpoint I suppose) pairing of ingredients for a topical treatment for rosacea symptoms.

If you search patents online you can also find applications for topicals containing Avermectin + Metronidazole and Avermectin + Hydrocortisone.

Galderma of course already make Benzoyl Peroxide based products such as Benzac AC and Epiduo.

United States Patent Application 20110003763

AVERMECTIN/BENZOYL PEROXIDE COMPOSITIONS FOR TREATING AFFLICTIONS OF THE SKIN, E.G., ROSACEA

The compounds of the avermectin family according to the present invention especially include invermectin, ivermectin, avermectin, abamectin, doramectin, eprinomectin and selamectin. The compound of the avermectin family is preferentially ivermectin.

In the compositions according to the invention, the said compound of the avermectin family is present in concentrations of from 0.001% to 10% by weight and preferably from 0.01% to 5% by weight relative to the total weight of the composition.

In the compositions according to the invention, the benzoyl peroxide is present in concentrations of from 0.01% to 30% by weight and preferably from 0.1% to 20% by weight and particularly preferably from 1% to 10% by weight relative to the total weight of the composition.

Benzoyl peroxide (or dibenzoyl peroxide) is known in the prior art for its anti-acne and keratolytic properties. Benzoyl peroxide has a bacteriostatic effect on Corynebacterium acnes, reduces the level of free fatty acids in sebaceous secretions and has strong oxidizing properties. Benzoyl peroxide is conventionally used in the treatment of common acne and, to a lesser extent, in the treatment of rosacea.

Ivermectin is known in the prior art for its anti-parasitic and anthelmintic properties. The anti-parasitic activity is thought to be due to the opening of a chlorine channel in the membrane of the neurons of the parasite under the effect of an increased release of the neuromediator GABA (gamma-aminobutyric acid), inducing neuromuscular paralysis that may lead to the death of certain parasites. Ivermectin also interacts with other chlorine channels, especially those dependent on the neuromediator GABA (gamma-aminobutyric acid).

Advantageously, the compositions of the invention comprise, other than the at least one compound of the avermectin family and benzoyl peroxide, at least one other therapeutic agent capable of increasing the efficacy of the treatment. Exemplary such agents include antibiotics, anti-bacterial agents, anti-viral agents, anti-parasitic agents, anti-fungal agents, anaesthetics, analgesics, anti-allergic agents, retinoids, free-radical scavengers, anti-pruritic agents, keratolytic agents, anti-seborrhoeic agents, anti-histamines, sulfides, and immunosuppressant or anti-proliferative products, or a mixture thereof.

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A recent press release from a company called Elorac, is highlighting Phase II trials for treating Acne with Carbamide Peroxide. Elorac are promoting Carbamide Peroxide as an improved, next-generation version of benzoyl peroxide.

Benzoyl Peroxide has not to date been commonly used as a rosacea treatment because of concerns about being too harsh for some rosacea sufferers. The preliminary results from Carbamide Peroxide suggest that it may be responsible for less skin irritation but might be just as effective as Benzoyl Peroxide.

Here is an extract of the press release from Elorac’s web site;

Elorac, Inc. Announces Clinical Results of Carbamide Peroxide Studies for the Treatment of Acne

November 18, 2010

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, announced results of two Phase III studies of its patented Carbamide Peroxide (CPO) solution for the treatment of inflammatory acne vulgaris and rosacea at the Lazard Capital Markets 7th Annual Healthcare Conference in New York.

Jeffrey Bernstein, Ph.D., Elorac’s President and CEO, commented, “We see a great market opportunity for Carbamide Peroxide in acne and rosacea. These are large markets. Branded topical products for acne and rosacea generate more than $1 billion in sales. CPO would be the first new topical product for acne and rosacea in several years. It’s an improved, next-generation version of benzoyl peroxide (BPO), which is the most commonly used product for acne.”

In two phase III pivotal double-blind, randomized, vehicle-controlled, paired-comparison, multi-center studies, the results showed statistically significant reductions in acne lesion counts after 8 and 12 weeks of treatment with CPO as compared to vehicle treatment.

Bernstein added, “The efficacy results for CPO are similar to those of previously approved topical acne products, but CPO has a distinct advantage in its tolerability. We have, in fact, clinical data comparing BPO and CPO in acne that demonstrates comparable efficacy, but documents significantly less local skin irritation in patients using CPO. We think that this superior tolerability also bodes well for the use of CPO in rosacea, where irritation is even more of an issue.”

Carbamide Peroxide, also known as urea peroxide, is perhaps best known as a teeth whitener.

Elorac was formerly known as Exopharma, and Exopharma are listed as the owner of a related patent; Method of Treating Inflammatory Acne Vulgaris with Carbamide Peroxide. This patent application would have to be the one of the shortest text I have read ! A couple of interesting extracts.

The applicant has discovered, quite surprisingly (and in direct opposition to the teaching in U.S. Pat. No. 4,607,101) that carbamide peroxide by itself is quite effective at treating the inflammatory lesions of acne vulgaris, and acne rosacea. The invention, therefore, encompasses an improved method of treating inflammatory acne vulgaris or rosacea utilizing application to the skin of solutions, creams, gels, or lotions containing carbamide peroxide

…

A 48-year-old female with rosacea and four acneform papular lesions of the nose and cheeks applied the 10% carbamide peroxide solution of Example 1 to her face three times daily for eight weeks. At the end of the eight weeks her face was clear of rosacea papules.

Elorac lists in their product pipeline a product known as E-0301. This product is indicated for Acne and Rosacea, with Acne being listed as being at Phase 3 status and Rosacea at Phase 2. The projected availability dates are 2013 and 2014 for E-0301 in Acne and Rosacea respectively.

Elorac already markets the following dermatology products;

• NicAzel for Acne. NicAzel is a dietary supplement  that is described as a “combination of ingredients shown to possess anti-inflammatory and anticomedonal activity.” The ingredients include Nicotinamide, Azelaic Acid, Zinc Oxide, Pyridoxine, Copper Oxide and Folic Acid. Interesting to see azelaic acid as an oral supplement.
• Durasal (Salicylic Acid 26%) for Warts.
• Zithranol-RR for Psoriasis. Zithranol is a topical cream that contains Anthranlin.

So it appears that we should add E-0301 to the list of rosacea treatments coming soon.

Related Articles

• Sol-Gel Trialling Benzoyl Peroxide (DER 45 EV) for Rosacea
• Trial Watch: New Treatments Coming Soon
• New Rosacea Treatments – get them while they’re hot