A paper that Rosacea News previewed in November last year: Accutane dose of 22mg a day works best: EADV has now been published in the JDDG: Journal of German Society of Dermatology.

As we learned from the EADV paper, the Spanish pharmaceutical company Almirall is hoping to promote their “branded version of isotretinoin in the treatment of rosacea.” It seems like a bold move; to attempt to market oral isotretinoin as an alternative to oral antibiotics.

For those enrolled in this blind study, 0.3 mg/kg per day was found to be as effective as 50mg a day of doxycycline at treating the papules, pustules and phymatous growth of rosacea.

Getting the dose right is important if you want to try Isotretinoin as a treatment for your troublesome rosacea. How do you know if you are taking too much ? A high dose of accutane can lead to unpleasant side effects and even worsen the flushing associated with rosacea.

If you consider an average weight of 166 pounds (around 75kg) this paper would lead to a recommended dosage of around 22mg a day. Even this amount may be viewed as moderate to high when compared to advice from Dr. Plewig that “doses of isotretinoin typically used in the United States and Europe are far too high. For many patients, as little as 2.5 mg twice a week, which he describes as `a drop of rain on a dusty road’ is adequate.”

For more information see what accutane dose works for rosacea ?

Systemic isotretinoin in the treatment of rosacea – doxycycline- and placebo-controlled, randomized clinical study. J Dtsch Dermatol Ges. 2010 Mar 12.

Authors: Gollnick H, Blume-Peytavi U, Szabó EL, Meyer KG, Hauptmann P, Popp G, Sebastian M, Zwingers T, Willers C, von der Weth R

Summary Background: Systemic isotretinoin has been known for decades to be effective in the treatment of severe forms of rosacea, but it must be used off-label because of the lack of evidence-based data.

Patients and Methods: 573 patients with rosacea subtype II and III received one of three different dosages of isotretinoin (0.1 mg, 0.3 mg, or 0.5 mg per kg body weight), doxycycline (100 mg daily for 14 days, then 50 mg daily) or placebo in a double-blinded, randomized way for 12 weeks in 35 German centers.

Results: Isotretinoin 0.3 mg/kg proved to be the most effective dose with significant superiority versus placebo. Isotretinoin 0.3 mg/kg showed also significant non-inferiority versus doxycycline with reduction of lesions of 90 % compared to 83 % with doxycycline. Investigators diagnosed complete remission in 24 % and marked improvement in further 57 % of patients with isotretinoin treatment, in contrast to remission in 14 % and marked improvement in 55 % of patients treated with doxycycline. Isotretinoin 0.3 mg/kg revealed a similar safety profile as for the treatment of acne. Isotretinoin 0.5 mg/kg showed more dermatitis facialis as compared to 0.3 mg/kg.

Conclusions: Isotretinoin 0.3 mg/kg is an effective and well-tolerated therapy option for the treatment of rosacea subtype II and III and can therefore be used successfully as an alternative to therapy with oral antibiotics.

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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.

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Here are example screen shots of what the introductory and red and blue screens look like when running the Acne Application.

AcneApp also scored a brief mention last December in the New York Times article Better Skin to the Touch? The piece offers the opinion from its creator that a lot more clinical study is required before any efficacy can be quantified. Dr. Pearson is said to fascinated by the concept of users treating their acne while talking on the phone.

An iPhone application is a small program that you can download and run on your phone.

According to a piece in WebMD, Dr. Pearson was not available to comment on the application, nor is his office able to comment on or support users of the application.

This application is no doubt only garnering publicity because it is not a free application. If the application was free it could easily be characterised as only being for entertainment value. Once an application costs money and looks like it treats a medical condition, it is natural for readers’ interests to be piqued.

So what is going on here ? The use of LED therapy to treat skin conditions is a hot topic. Various studies have shown that red and blue LEDs can offer anti-inflammatory benefits to some of the symptoms of acne and rosacea. The display on the iPhone is a LED display. The makers of this phone application want us to make the leap of faith that because the iPhone can display colors that are thought to be helpful, LED therapy is literally just a phone call away.

Dr. Pariser, president of the AAD says that the output from the iPhone would need to increase a thousands times to match treatments available from professional LED treatments.

Can You Treat Acne With an iPhone App?

AcneApp Promises to Clear Skin With Light Therapy; Dermatologists Express Doubts

By Kathleen Doheny, WebMD Health News. Reviewed By Louise Chang, MD

Feb. 12, 2010 — iPhone users love their apps, so it’s no surprise that AcneApp, a light-based therapy, is drawing interest from the blemish-prone who like the concept of zapping zits while talking to friends.

It’s supposed to work like this: Download the application and hold the phone to the skin so the light therapy can do its work. Multitask if you wish, remembering to switch sides so your entire face gets the treatment.

But more than four months after its release, there are still no clinical studies proving it works. Other dermatologists express doubt it could help, and users are giving it mixed reviews — from terrific to skeptical.

…

Though the wavelength of light used in the AcneApp is similar to that used in office-based light treatments, the intensity of the light used by dermatologists "is at least thousands of times greater," agrees David Pariser, MD, a Norfolk, Va., dermatologist and president of the American Academy of Dermatology. "I would be very surprised if there is enough intensity of the light [from AcneApp] to make any difference."

…

So aside from wasting $1.99 and still coping with zits, is there any potential harm?

Yes, Rahimi says. "I am worried about the patient with deep cystic acne and open, draining sores that uses this app." Bacteria on the phone could lead to a skin infection, he says.

The application is available from the iTunes Store: AcneApp, but I wouldn’t recommend it.

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A recent abstract has highlighted some new acne treatments that perhaps many haven’t heard of before.  As these treatments might not be on the radar for rosacea sufferers I thought it might be useful to highlight them here.

Veteran rosacea sufferers will know that many acne treatments are too harsh for rosacea sufferers. Experience seems to show though, that some rosacea sufferers can tolerate acne treatments and may even see some benefits for the papules and pustules of their rosacea.

Picolinic Acid

Touted as “a novel zinc finger therapy”, piolinic acid, was reported to be effective in the treatment of mild-to-moderate acne vulgaris in 20 subjects receiving 10% picolinic acid gel twice daily to the face over 12 weeks, of which 15 patients completed the 12-week open-label study

Topical Antibiotic Dapsone

The U.S. Food and Drug Administration (FDA) has approved Aczone (dapsone) Gel, 5% for the topical treatment of acne vulgaris in patients 12 years and older. Aczone is also being promoted as a treatment for adult acne. This seems to confirm my thought that Allergan would like to market aczone as a rosacea treatment.

Systemic Zinc Salts

I found this topic tricky to research. There are plenty of resources that want to sell you zinc in many forms. What constitutes `emerging oral zinc therapy’ isn’t clear to me. Please post in the comments below if you know what the authors are referring to.

Could the author be referring to treating rosacea with zinc sulfate, where trialists were using zinc sulfate 220 mg bis for 90 days?

Oral Antibiotic Lymecycline

Lymecycline is an antibiotic from the tetracycline family. It is marketed by Galderma. It has been available since 1963 so it doesn’t seem that this is such a new or innovative treatment.

Synergistic combinations of Benzoyl Peroxide

Benzoyl Peroxide has been around for many years. One abstract I found suggested ;

A Current Review of Topical Benzoyl Peroxide: New Perspectives on Formulation and Utilization

As numerous clinical studies have shown, the combination of BPO plus a topical antibiotic is not only more effective but also is often better tolerated than either agent alone. Unlike antibiotics, no bacterial resistance has been noted. Adding BPO to any long-term antibiotic regimen in acne is generally recommended to help reduce populations of drug-resistant variants.

Photodynamic Therapy with topical photosensitizers

Photodynamic Therapy (PDT) has been covered several times before on this blog. This treatment looks to be useful to topical skin conditions, but it is not clear yet whether it is generally suitable as a rosacea treatment.

Potential Acne Vaccines

A 2008 paper in The Journal of Investigative Dermatology raises the possibility of a vaccine that allow the immune system to better react to exposure to P. acnes and also slow the growth of skin bacteria.

Acne Vaccines: Therapeutic Option for the Treatment of Acne Vulgaris?

Acne, one of the most common skin diseases, is caused by multiple factors, including Propionibacterium acnes. Studies suggest that responses to P. acnes by host immunity play important roles in its pathogenesis. Identifying immune modulators that attenuate inflammatory responses against P. acnes and the inhibition of bacterial growth may lead to novel avenues of immunologic intervention.

Here is the abstract of the paper covering the emerging treatments for acne.

Emerging drugs for acne, Expert Opin Emerg Drugs. 2009 Dec;14(4):649-59.

Acne vulgaris is a common skin disorder that affects most individuals at some point in their lives. It may result in significant morbidity, including cutaneous scarring and psychological impairment. Current treatments include topical retinoids, benzoyl peroxide, topical and systemic antibiotics, and systemic isotretinoin. There are growing concerns of rising antibiotic resistance, significant side effects of isotretinoin therapy, and lack of safe and effective treatment for pregnant females. Recent advances in the pathogenesis of acne have led to a greater understanding of the underlying inflammatory mechanisms and the role the Propionibacterium acnes and biofilms. This has led to the development of new therapeutic targets. This article reviews emerging treatments of acne, including topical picolinic acid, topical antibiotic dapsone, systemic zinc salts, oral antibiotic lymecycline, new formulations of and synergistic combinations of benzoyl peroxide, photodynamic therapy with topical photosensitizers and potential acne vaccines.

Your Thoughts

What do you think about acne treatments and your rosacea ? Do you think rosacea sufferers might be missing out on some options by ignoring treatments that are only promoted to treat acne ?

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In an ELLE Magazine December 2009 interview, New York Dermatologist Macrene Alexiades-Armenakas, MD, PhD tells us that she has rosacea.

A respected and published dermatologist, Dr. Alexiades-Armenakas says that she is one of the many people who cannot tolerate topical retinoids. Instead she prefers Finacea which she says is great for acne and rosacea, reduces oiliness and lightens brown spots, great for breakouts.

As an aside, given that she sufferers from rosacea, I wonder what sorts of results she sees herself from her own `high performance anti-aging cream’ known as dr.macrene 37 Extreme Actives. Sadly at $275 for 50ml I don’t think many will want to just try-see. If you are interested, here is the dizzying list of ingredients listed by DNA repair, cellular repair, anti-pigment, anti-red, anti-wrinkle, anti-oxidant, pro-collagen, barrier repair properties, to name a few.

Skin Care Made Simple: Tips for Wrinkles, Blemishes, and Redness

An NYC dermatologist shares her beauty secrets—and reveals a new superproduct.

Is Retin-A still the gold standard for anti-aging?
Retinoids have the longest track record, and they’re great for antiacne. But many people, like me, can’t tolerate them. Instead, I use the azelaic-acidbased prescription Finacea, which works on both rosacea and acne and also reduces oiliness, lightens brown spots, and is a great spot therapy for breakouts—it won’t make you red and flaky the next day.

Rosacea? You don’t look red.
Some doctors don’t agree with me on this, but rosacea is very common. By definition, if you stay red and you start to get broken capillaries and bumps, that’s rosacea. Hot weather, showers, drinks, and certain foods can cause flare-ups. Reduce these and you’ll see a change—fast.

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News today that Sol-Gel Technologies has filed for Investigational New Drug for a product they are calling DED45-EV. This topical gel is targeted as a treatment for rosacea.

There doesn’t seem to be other copies of this release, or related information so this could just be a pure PR exercise.

The exact details of the active ingredients in this product are not being made public. So far, only PR speak along the lines of ““As Sol-Gel’s microcapsulation forms a protective barrier between the drug and the skin, we expect it to reduce irritation when applied to the relatively sensitive skin of rosacea patients,“said Dr. Stanley Shapiro, Sol-Gel’s Head of Skin Care Science & Technology.” is being published.

My guess back in July in Sol-Gel Trialling Benzoyl Peroxide (DER 45 EV) for Rosacea ? was that this topical gel was in fact benzoyl peroxide. Certainly the publicity so far from Sol-Gel has been related to acne and acne treatments.

Sol-Gel Anti-Acne Clinical Study Shows Significantly Improved Efficacy and Safety

“In the Sol-Gel kits, the proprietary silica microcapsules encase and continuously release the benzoyl peroxide, enabling a significant increase in efficacy and tolerance in comparison to products containing free benzoyl peroxide

As I said in July, many rosacea sufferers will know from their own experiences, many acne treatments are just too harsh for their sensitive rosacea skin.

If anyone sees some more information that confirms the makeup of DER45-EV please do let us know.

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WARNING LETTER

The FDA has reviewed a journal advertisement (APC021052008) for ACZONE® (dapsone) Gel, 5% (ACZONE) (and) this journal advertisement is false or misleading because it grossly overstates the efficacy of ACZONE, and omits material facts and important risk information associated with the use of the product.

The offending advertising claims.

The journal article overstates the effectiveness of Aczone by neglecting to state that at 2 weeks usage, Aczone was only 2% more effective than the placebo vehicle gel. This small difference is not considered statistically significant so it not a true claim of efficacy. The 12 week trial results were also over stated by ignoring the comparative effect of the vehicle gel.

The second part of the warning deals with the omission of important risk information associated with Aczone. Clinical trials found that 7 out of 95 subjects who applied benzoyl peroxide after applying Aczone had yellow or orange discoloration of the skin and facial hair. This discoloration took between 4 and 57 days to resolve.

The FDA attracts a lot of criticism from rosacea sufferers who see the organisation as overly bureaucratic and unnecessarily slowing down new drug applications. We do need a policeman to help protect us from cynical vendors who make claims that are not based on proven facts. Personally I’m glad that the FDA is willing to publicise vendors who try to take advantage of rosacea sufferers.

An important message here is that rosacea sufferers would be wise to be wary of statistical claims in advertising materials. Seek out published proof before believe what you read.

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Clinical Trial NCT00940992, A Dose-Range of DER 45-EV in Treatment of Rosacea (SGT-EBPO1-09)

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

DER 45 EV Gel, 1%: Experimental, vs. Placebo Gel applied topically once a day for 12 weeks, vs. DER 45 EV Gel, 5% applied topically once a day for 12 weeks.

It isn’t clear if DER 45 EV is in fact benzoyl peroxide, this is just a guess based on the technologies being promoted by the company sponsoring this trial, Sol-Gel. The company’s technology is to use silica based microcapsules (cutely named Cool Pearls) that will allow a continual release of the active ingredient. Their Anti-Acne kit consists of a cleanser, toner, lotion and also spot treatment.

Sol-Gel Anti-Acne Clinical Study Shows Significantly Improved Efficacy and Safety

The results demonstrate that the company’s two strength Anti-Acne kits achieved pronounced efficacy and markedly improved tolerability.

…

“In the Sol-Gel kits, the proprietary silica microcapsules encase and continuously release the benzoyl peroxide, enabling a significant increase in efficacy and tolerance in comparison to products containing free benzoyl peroxide,”

The marketing material for Sol-Gel Technologies gives the following description of the process behind creating their products – “Silicate materials are made by forming interconnections among colloidal nano-sized particles (the sol) under increasing viscosity, until a rigid mass is formed with about half the density of glass (the gel). Sol-Gel precisely engineers the process to fine-tune the size, structure and properties of the materials formed. The resulting drug delivery properties range from completely non-leachable to a selectively porous barrier that allows controlled release of active ingredients after the product is applied to the skin.”

The trial is listed to start in January 2010 so perhaps we will be able to find out more information before then.

This is a potentially interesting development, especially if this means that a harsh treatments such as benzoyl peroxide is tolerable by and beneficial to rosacea sufferers.

As many rosacea sufferers will know from their own experiences, many acne treatments are just too harsh for their sensitive rosacea skin.

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Just posted on the clinicaltrials.gov database is an entry “Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea”. This topical product, known as Ziana, is currently approved for the treatment of acne.

Ziana is manufactured by Medicis who also make Plexion and Solodyn. The combination of tretinoin and clindamycin may be too harsh for some rosacea sufferers, so it will be interesting to see how the trial pans out. Ziana is marketed as the only topical to combine an antibiotic and a retinoid.

The trial will primarily measure a reduction in the count of papules and pustules from baseline to week 12. A secondary measurement will be transient redness. We can deduce from this that Ziana is only thought to be effective against the inflammatory lesions of rosacea, and will likely only have a mild effect on the redness.

Rosacea sufferers have many choices to treat papules and pustules, so sufferers may well be left wondering, why one more ? If you can’t tolerate metrogel, metrolotion, metrocream, noritate, topical clindamycin, finacea or plexion (just to name a few), then maybe, at a stretch, Ziana might offer you another viable option.

Have you tried Ziana for your rosacea ? How did you find it ?

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A question we hear from time to time from rosacea sufferers is `how do I go about reducing the size of my skin pores ?’ This is quite a difficult question to properly answer. The enlarged pores that you sometimes see with rosacea or acne can feel like they will never go away.

You are here on this page because you feel sure that there must be a way to reduce the inflammation that leads to swollen pores on your face.

Here are some insightful thoughts from Dr. Linda Sy;

Pores can appear enlarged if filled with sebum & keratinized cells. When the epithelial cells are exfoliated or the sebum production is inhibited (example: by topical tretinoin or accutane prescription), the pores appear smaller. Therefore, any prescription that will reduce accumulation of sebum & keratin in the pores, will most likely help reduce the size.

I doubt that many doctors would recommend that you undertake a treatment regime of accutane just to reduce visible facial pores. If you also have the lump and bumps of acne, or severe pustules and redness of rosacea, you may find accutane is helpful in reducing the pore size also.

The NRS Ask the Doctors Blog also has a post asking Rosacea has made the pores on my face large. When I get my rosacea under control, will my pores return to their normal size?

The Rosacea Experts also come to a similar conclusion as Dr. Sy;

Topical and oral antibiotic therapy may be prescribed for mild cases, but more severe cases may sometimes be treated with isotretinoin, which is an oral medication typically used for severe acne. Clinical studies have shown that patients’ large sebaceous glands were diminished in size and number during isotretinoin therapy. There is also evidence that retinoids, topical medications with many of the same properties of isotretinoin, may decrease skin thickening and sebaceous gland enlargement. Spironolactone, a mild diuretic with anti-androgen properties, can also be used to decrease pore size.

Good to see some more suggested treatments for enlarged pores as I know this is something that worries many rosacea sufferers.

Featured Product

Over To You

Please leave a comment below with any hints or tips you have found that have helped you answer the question “how do I reduce the size of my pores ?”

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