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.

Related Articles

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

Microskin mention rosacea as one of the conditions that they treat. The product is slated as a simulated second skin. The product is applied using a Stipple (a special type of sponge) or an air brush for larger areas.

The company says that the product will not rub off, is completely waterproof, allows the skin to breathe and sweat, and lasts for several days.

The New York Times published an article on February 24, 2010 that highlighted the use of microskin as a coverup for Vitiligo.

Vitiligo: Ignoring What Is Painfully Obvious

Starting on Friday, vitiligo patients will have an alternative stateside. Microskin — a simulated second skin that’s been available in Australia for years — is set to open its first outpost in the United States at the Laser and Skin Surgery Center of New York, in Midtown. Microskin is formulated to bridge the gap between a vitiligo patient’s paler patches and unaffected skin so that skin tone appears even. (It can also cover burns, birthmarks and the effects of psoriasis.)

Each shade is customized. “There’s only one skin color for one person in the world,” said Linda Lowndes, who founded Microskin in 2005 after working as a makeup artist. “I don’t care if you’re black or white.”

Microskin is waterproof and won’t rub off on clothing. “You’ve got to use a removing serum to break the barrier,” she said, referring to a liquid that is included in the Microskin system.

…

Still, at the start, applying Microskin on his face, arms and legs would take 75 minutes, which was “pretty annoying,” he said. He does his face daily, but Microskin lasts for a few days elsewhere. And practice has made the application faster.

The Microskin system, with training, starts at $670 for sponge application and rises to $2,250 for airbrush application. Seasonal scans ($200) are recommended to update your Microskin shade.

The article also mentions Dermablend, ColorTration and Cover FX as options for covering up

Another option is camouflage. Some patients with vitiligo, rosacea or birthmarks rely on opaque foundations specially marketed to mask them. Dermablend and ColorTration are two. Lee Thomas, a television broadcaster who wrote a book about his vitiligo called “Turning White,” endorses another foundation, Cover FX, on his Web site.

For more information about Microskin see:

US Site: http://www.microskincenter.com/

Australian site: http://www.microskin.com.au/

Microskin has been in contact with me in the past and say that they have seen rosacea patients. Microskin received national coverage in a 2006 item on A Current Affair titled Second Skin (the video link to the article doesn’t appear to work).

There are very few good treatments for the redness of rosacea. Being able to cover the red angry face of rosacea can do wonders for self esteem.

Would love to hear from anyone who tries it to cover up their rosacea.

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When rosacea sufferers are first diagnosed it can be confusing to know how to include prescription topicals into their daily skincare regime. Rosacea patients want to know both that their expensive prescription medication has the best chance of working and that their current skin care system can still work.

In the most recent `Ask a Doctor’ column at the NRS web site Dr. Draelos confirms that rosacea topicals should be applied before any moisturizer or sunscreen or makeup.

Am I able to put a moisturizer over the topical therapy before I apply my makeup?

Yes, moisturizer may be used after applying topical medication without affecting the therapeutic outcome of your prescription. In fact, moisturizer may often be of help in preventing the burning, stinging, itching and irritation associated with rosacea.

I usually advise my patients to wait five to 10 minutes after applying a topical medication before applying a moisturizer, and then wait another five to 10 minutes before applying makeup. This will give your skin a chance to better absorb the medication and keep it from coming off on your fingers as you apply the moisturizer. Waiting before applying makeup may in turn improve cosmetic results.

This confirms the view held by Dr. Powell in his landmark book Rosacea: Diagnosis and Management. In Chapter 8 Dr. Powell tells us in italics that Drugs have priority-they go on first !

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The Clinical Trials register has listed a just completed trial for something cryptically called 0444 Gel. The Gel is targeted for the papules and pustules of rosacea. Apparently the study started in January 2008 and has just been completed.

Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea

Sponsor: Nycomed US Inc

The aim of this trial is to assess the efficacy of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea.

Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.

So what could this gel be ? As far as I can see, likely candidates include Solaraze as well as a new generic form of metrogel. These two classes of products are manufactured by companies related to or owned by Nycomed.

Solaraze

We learnt from a 2006 AAD Poster Session that Solaraze was being studied as a treatment for rosacea. SOLARAZE (diclofenac sodium-3%) Gel is indicated for the topical treatment of actinic keratoses (AKs).

SOLARAZE Gel is a registered trademarks of PharmaDerm, a Division of Nycomed US, Inc.

Solaraze is currently marketed in the US, Europe and Australia.

Generic Metrogel

Nycomed has a sister division Fougera Generics. A press release in 2005 alterted us to the fact that Fougera was poised to make generic metrogel 0.75%. Indeed you can find details on Fougera’s web site for Metronidazole Topical Lotion 0.75% (compares to MetroLotion) and Metronidazole Topical Cream 0.75% (compares to MetroCream).

Other Guesses

Any other guesses ? If you have more information about 0444 Gel please post in the comments below.

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I was alerted to the launch of a product called Promiseb by a comment left on the Sebclair for Seborrheic Dermatitis post. Since then the news web sites are also covering the press release. Promiseb (probably pronounced Promi-seb) is launching in the U.S. via Promius Pharma, after being licensed from Sinclair Pharma in 2007.

Promiseb Topical Cream (Sebclair) is a non-steroidal, prescription only cream for the treatment of seborrheic dermatitis. It has demonstrated anti-inflammatory and anti-fungal properties. Sebclair is approved for use in the European Union to treat seborrheic dermatitis. One of Sebclair’s (and now Promiseb’s) claims to fame is that it contains no corticosteroids or immunomodulating agents.

Promiseb is claimed to “Significantly reduced Malassezia yeasts, the organisms that may cause seborrheic dermatitis, by 94%”. These claims are more interesting when you consider the ongoing discussions like Malassezia Globosa causes seborrhea, Pyrithione Zinc is effective, Could M. Globosa Cause Rosacea? and Real cause of seborrhea discovered!.

For a description of the ingredients and suggested method of action see Sebclair for seborrheic dermatitis.

From the press release: Sebclair launched in the US by Dr Reddy’s Laboratories’  subsidiary Promius Pharma, LLC

Jeff Wasserstein, President of Promius Pharma, said “We are very excited about Promiseb Cream because it has the potential to replace both anti-inflammatoryand antifungal treatments in patients with seborrheic dermatitis. In a clinicalstudy Promiseb was shown to have efficacy comparable to desonide cream 0.05% atdays 14 and 28 with fewer relapses.

“Promiseb Cream also has an excellent safety profile with no restrictions onage, duration of use or application on the face.” He continued, “We are very enthusiastic about this product because our clinical research shows thatPromiseb Cream may be used as a first-line treatment for seborrheic flares andfor long-term maintenance”

A supporting web site for Promiseb is online at http://promiseb.com/.

[update:] Auburn-NH has posted an early review of Promiseb, from using a doctor supplied sample.

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This post-treatment therapy is in addition to some other recently published research that patients treated immediately after IPL with a LED device showed that their post-treatment redness subsided faster compared to not also being treated with LED.

We also know that 2% polyphenone in a hydrophilic cream has shown promise as a treatment for the papules and pustules of rosacea.

Topical polyphenolic antioxidants reduce the adverse effects of intense pulsed light therapy, J Cosmet Laser Ther. 2009 May 27:1-4, Freedman BM., Plastic Surgery Associates of Northern Virginia, McLean, Virginia, USA.

Background: Intense pulsed light therapy (IPL) has been associated with erythema and increased lipid peroxidation. Polyphenolic antioxidants have been shown to decrease inflammation and reduce oxidative stress in irradiated skin.

Objective: To determine whether the topical application of polyphenolic antioxidants to IPL-treated skin reduced the adverse effects of IPL exposure.

Methods: In a split-face study, 10 volunteers underwent three full-face IPL treatments (16 J/cm(2), 10ms, 560nm filter) spaced 3 weeks apart. A polyphenolic antioxidant solution was pneumatically applied to the left side of the face, beginning immediately before the first IPL treatment then weekly for six treatments. The lipid peroxide concentration, skin antioxidant level and skin moisture content were obtained before and after the study.

Results: Skin treated with IPL alone contained a significantly higher concentration of lipid peroxides when compared to skin treated with IPL plus polyphenolic antioxidants (p<0.05). Skin treated with IPL alone contained a significantly lower level of polyphenolic antioxidants and had a significantly lower moisture content (p<0.05).

Conclusions: In this study, the concurrent pneumatic topical application of polyphenolic antioxidants reduced lipid peroxidation and skin dehydration in IPL-treated skin. Polyphenolic antioxidants may confer a protective effect on facial skin and enhance the effects of IPL therapy.

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Showing just how important the internet is becoming for marketing new cosmetics, Pyratine XR has recently launched with a lot of press activity. As well as Senetek’s press releases on the internet I was also contacted by 2 PR representatives trying to get me to cover the release of this `new’ product. Pyratine XR was launched at the South Beach Dermatology Symposium in Miami on Feb 14 and also on March 6 at the AAD Annual Meeting in San Francisco.

The press release activity is based on an as-yet unpublished study of 18 mild to moderate rosacea over a period of 48 weeks.

So what is the difference between Kinerase, Pyratine-6 and Pyratine XR ? Well firstly they are all expensive over the counter cosmetics. The active ingredient in these products is furfuryl tetrahydropyranyladenine. As cosmetic products none of these can make claims to treat any particular disease.

Kinerase

Kinerase Cream contains 0.1% N6-furfuryladenine.

The ingredients of Kinerase are listed as: purified water, glyceryl stearate and laureth-23, isopropyl palmitate, propylene glycol, stearic acid, cetyl alcohol, carthamus tinctorius (safflower) seed oil, soya sterol, stearyl alcohol, dimethicone, imidazolidinyl urea, citric acid, sodium hydroxide, methylparaben, soluble collagen, carbomer, N6-furfuryladenine, panthenol, propylparaben, triethanolamine, ascorbic acid, hydrolyzed elastin, and aloe barbadensis leaf juice.

Pyratine-6

Pyratine 6 contains 0.1% N6-furfuryladenine and is marketed as an anti-aging product and as Senetek’s `second-generation patented cytokinin’

Pyratine XR

Pyratine XR contains 0.125% N6-furfuryladenine and is marketed as a rosacea product once Senetek increased the amount of the active ingredient and initiated the unpublished study mentioned in this article. It looks to me that the Red R in the labelling is also trying to suggest that this product is for rosacea sufferers.

Product Feedback

There is some strong skepticism about Pyratine XR over at the Rosacea Forum

I agree with Melissa:

1. The stuff is ridiculously expensive
2. It went “cosmetic” as to avoid having to conduct rigorous testing
3. It’s claims are yet to be approved by the FDA as far as I could find
4. There are no 3rd party tests of this product, only in house research done by the company
5. In the tests that were done the claim was that it was tested on people with mild to moderate rosacea, but the test data itself remains largely unpublished.
   Further: http://www.dermatology.uci.edu/IID%2…er%20final.pdf
   Are you kidding me? If the two test subjects pictured are the best examples to sell this product then it appears to only work well for those with really, really, really mild Rosacea.
6. I haven’t heard one good thing about Pyratine 6 from a real Rosacea sufferer, it is hard to imagine why this is going to be that much better
7. Spamming Rosacea web boards for business suggests a $ grab
8. I don’t know why this plant derivative substance is significantly different from others that have been around for some time that claim to also be anti-inflammatory and effective on ROS.
   Bottom line, there is no real reason to believe this product will work imo, but the jury is out. Once is comes out, if some reliable people post good results it might be worth a try. I would prefer seeing a large scale 3rd party double blind study on it.

Pyratine XR was due to be launched at the SF AAD Meeting. An interesting post from badhairday gives some insight into what this launch actually meant ;

Hi all,

Thought this would be helpful info re: Pyratine XR. I realize I don’t regularly post but I thought this was important. My sister in-law is a Derm. She attended the National Dermatology Conference in San Francisco this past weekend. I asked her to find this product and try to get me the inside scoop – like all of us I am cautiously hopeful of anything new but also skeptical. Here’s what she found.

The Pyratine XR booth – was a VERY hard to find tiny booth. There were two women representing the product (she said the ladies seemed a little sketchy – not necessarily important info but I trust my sisters judgement ). Just a few before and after pictures of people who had trialed it for 48 weeks – but NO real data on how the product works and the women wouldn’t get into any detail. They would only conditionally commit to give her 6 free samples (enough for the 48 months per patient) BUT the Dr. had to commit to recording results of their patients (data and pictures) through the period of the trial and report back to the company. If the Dr. didn’t want to commit to the following though on data gathering they would need to pay $400 + per patient (for an 48 month trial). This product will be sold over the counter only in physician offices (no pharmacies). My sister-in-law was concerned that this company was trying to solicit Doctors to do the research for them for free rather than setting up an actual study where patients are paid. Further she was sceptical that they wouldn’t give any free samples (it is $150 per tube!)

She reported that b/c it’s over the counter it doesn’t have to go though any “real” testing (a lot easier to get approved). Just need to prove that it doesn’t harm anyone. It seems to be a glorified anti aging product with natural plant exact ingredients which probably will be ok for many of us to use as most of the ingredients looked fairly benign. But it’s hard to say if it will have any effect on rosacea at this point. Her recommendation was to wait a year and not spend the money as it didn’t look promising enough and it didn’t have enough to back it up that would make it a worth while product at this point. Sorry to burst any bubbles – and again what doesn’t work for one may work for another and obviously a few people on this sight have had some luck. The product representation just seemed a little sketchy for me.

Good luck all – hope this helps a few of us to save a few bucks and… Jen

Paula Begoun has this to say about Kinetin.

Kinetin is a plant-growth hormone, and its technical name is N6-furfuryladenine. What makes kinetin interesting are the in vitro and animal studies demonstrating its effect as a growth factor.

…

I suspect that when it’s applied topically, kinetin isn’t of much use to the skin cell, and even if it could be utilized, there probably isn’t enough kinetin in any product to have a negative or positive impact but that is only a guess, no one knows for sure (Source: Dermatologic Clinics, October 2000, pages 609-615).

User Reviews & Feedback

As Pyratine XR has only recently launched there aren’t many testimonials available yet. Here are some thoughts from users of the related product Pyratine 6.

From DukeCity; I still am using the creme and think it’s the best moisturizer I’ve ever had, as far as toning down redness it’s so subjective, as I’ve had multiple IPL/Laser TX and am taking Oracea daily. But it is the only topical I’ve been using since last Feb./March. I will definitly be buying the Pyratine/RX as soon as it comes to public sale…

From dallascowgirl; On March 14, 2009, I will have completed a year using Pyratine- 6 lotion. (I tried the cream but it made my skin break out.) I still like it as much as ever– the first moisterizer I’ve ever been able to use. In this year, I have only used two 2.5 oz. tubes. I use a pea size glop twice a day while my face is slightly damp. I have had acne rosacea since I was 13 years old. Today, I have no breakout and my face skin is smooth, a little pink on my chin. Though it is expensive, I think I’ve actually saved money this year from not running out and buying the newest cream every month. Will I try the the new one? I really haven’t decided yet.

From sophie; I started using Pyratine last sept or oct, and loved my skin more after only a week or two. There has been a SMALL reduction in P&Ps [I still have them]. Likewise a SMALL reduction in redness [I'm still red]. The BIG difference was in the overall smoothness of my skin. Its still rougher than your average persons, but I’m quite sure that its the smoothest its been since pre-puberty [I'm now 33]. Funnily enough, I wonder whether my spider veins are now more defined now cause my skin is clearer. The other downside is that prolonged use hasn’t made my skin any better i.e. the almost immediate improvement has remained but not increased.

Over to You

So now that you have read all this background information, do you plan on trying Pyratine XR ?

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So now you know; you can apply your topicals before or after you moisturize and it won’t make any difference.

Impact of order of application of moisturizers on percutaneous absorption kinetics: evaluation of sequential application of moisturizer lotions and azelaic acid gel 15% using a human skin model, Cutis. 2009 Mar; 83(3):119-24., Del Rosso JQ, Lehman PA, Raney SG., Valley Hospital Medical Center, Las Vegas, Nevada, USA.

The medical management of rosacea increasingly has involved not only the appropriate selection of topical medication but also patient education and specific recommendations regarding appropriate skin care. The recognition that epidermal barrier dysfunction and transepidermal water loss (TEWL) play a pathophysiologic role in rosacea and that skin moisturization may help to mitigate signs and symptoms of the disease has led to a deeper appreciation of the importance of proper skin care in the treatment of rosacea. Data from a percutaneous penetration study performed using human skin suggest that any of the tested moisturizer lotions may be applied either before or after azelaic acid gel 15% without a major change in the percutaneous absorption profile of azelaic acid.

[Update]: a quote from Dr. Powell’s excellent book: Rosacea Diagnosis and Management says that  the medicine should always go on first; Drugs have priority-they go on first ! he tells us in italics.

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Continuing recent consolidations in the pharmaceutical industry is the report that the giant GlaxoSmithKline (or GSK) are to purchase Stiefel. Stiefel is the manufacturer of Rosac Wash and Rosac cream with Sunscreens. Stiefel is also the makers of Rosasol – a formulation of metronidazole with SPF15 available in Canada.

Stiefel is also a supporter of the National Rosacea Society, having offered unrestricted educational grants in the past.

Rosac is a topical preparation that combines 2 sunscreens with sodium sulfacetamide and sulfur.

GSK is not known for its rosacea products, perhaps the closest they have ventured so far is Spectro Jel.

WSJ: GlaxoSmithKline May Buy Stiefel for $3B

GlaxoSmithKline (GSK: 30.61, -0.25, -0.81%) is close to a deal to acquire Stiefel Laboratories for around $3 billion, The Wall Street Journal reported, citing people familiar with the matter.

Major pharmaceutical industry players are rushing to merge to beat back growing competition from generic drug makers and replenish their product pipelines. So far this year a number of deals have been announced, such as Pfizer’s (PFE: 14.18, 0.29, 2.09%) pending buyout of Wyeth (WYE: 43.24, 0.37, 0.86%) and Merck’s (MRK: 25.7963, -0.0537, -0.21%) pending takeover of Schering-Plough (SGP: 23.4, 0.13, 0.56%).

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ADMINISTRATION OF TROPISETRON FOR TREATING INFLAMMATORY SKIN DISEASES/DISORDERS, United States Patent Application 20090048289.

Tropisetron or salt thereof, formulated into diverse pharmaceutical/dermatological compositions, is useful for the treatment of a variety of inflammatory skin disorders/diseases, e.g., eczema, psoriasis, rosacea, acne vulgaris, ulcers, seborrhoeic dermatitis and irritations induced by chemical, physical or mechanical agents, notably rosacea.

Tropisetron has been approved in the past in palliative therapy to prevent or treat chemotherapy induced nausea and vomiting and to treat post-operative nausea and vomiting. Tropisetron is not available in the United States.

Tropisetron has been found effective in treating rheumatic arthritis, IBS, diarrhoea, central nervous system related disorders like anxiety, drug addiction, cognitive functions, myofascial pain, chronic fatigue syndrome, fibromyalgia and certain forms of pruritus.

Further, Claim 8 in the patent application is interesting;  “there is, however, no published data regarding the use of tropisetron in order to treat an inflammatory skin disorder/disease and preferably rosacea”. If indeed Galderma have found this agent to be effective in treating rosacea, they may well end up owning the patent outright.

The claims proposed in the patent embody a topical agent being a gel, cream or lotion with a concentration from 0.0001% to 20%. The claims also mention topical application to the eye and cover oral and sub cutaneous preparations as well.

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