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.

Related Articles

• Promiseb Prescribing Information
• Malassezia Globosa causes seborrhea, Pyrithione Zinc is effective
• Sebclair for seborrheic dermatitis
• Sebclair / Atopiclair available in Australia

Residents of Australia may not know that Finacea is available Over The Counter. See also the ongoing comment thread on the Rosacea News item: focus on finacea.

Facial seborrheic dermatitis: a report on current status and therapeutic horizons, J Drugs Dermatol. 2009 Feb;8(2):125-33, Bikowski J

Seborrheic dermatitis, characterized by erythema and/or flaking or scaling in areas of high sebaceous activity, affects up to 5% of the US population and often appears in conjunction with other common skin disorders, such as rosacea and acne. Despite ongoing research, its etiology is puzzling. Increased sebaceous and hormonal (androgenic) activity is thought to play a part. Recent evidence suggests an important role for individual susceptibility to irritant metabolites of the skin commensal Malassezia, most probably M globosa. Current approaches thus include agents with antifungal as well as antikeratinizing, and anti-inflammatory activity. Azelaic acid, which has all 3 properties, may be a useful addition to first-line management, which now comprises of topical steroids, the immunosuppressant agents tacrolimus and pimecrolimus, azoles and other antifungals, and keratolytic agents. A recent exploratory study supports the efficacy and safety of azelaic acid 15% gel in seborrheic dermatitis. Azelaic acid may be especially valuable in this application because of its efficacy in treating concomitant rosacea and acne.

Related Articles

• Finacea Fact Sheet
• Sebclair / Atopiclair available in Australia
• Sebclair for seborrheic dermatitis
• metrogel also works for seborrheic dermatitis
• NRS on seborrheic dermatitis
• Malassezia Globosa causes seborrhea, Pyrithione Zinc is effective
• Xolegel for treating seborrheic dermatitis (seb derm)
• sebazole (topical ketoconazole gel 2%) low systemic absorption for short treatment periods

It appears to be called Atopiclair and is available from
http://www.atopiclair.com.au/ It is listed as Atopiclair Cream 40ml and is $49 including postage to anywhere in Australia.

The web site claims a “new, non-steroidal cream that is designed to relieve the symptoms and signs of eczema (atopic dermatitis) and allergic dermatitis (contact dermatitis).”

Going by the papers they cite on that page and the paper above both quoting MAS063DP (Atopiclair[TM]), and the fact that Otco Global is listed as the Australian distributor – I’d say that this is Sebclair.

Sebclair (MAS064D) is approved for use in the European Union to treat seborrheic dermatitis. One of Sebclair’s claim to fame is that it contains no corticosteroids or immunomodulating agents. The paper’s authors admit that it is difficult to know which compound is responsible for Sebclair’s success as a treatment.

The authors state “We believe that the major activity is probably due to the synergistic effect of both piroctone olamine, for its antimycotic action, and glycyrrhetinic acid, for its anti-inflammatory action.”

Related Articles

• Sebclair for seborrheic dermatitis
• Malassezia Globosa causes seborrhea, Pyrithione Zinc is effective
• Xolegel for treating seborrheic dermatitis (seb derm)
• treating seborrheic dermatitis with itraconazole (sporanox)

Although the two disorders are unrelated, a recent clinical study found that 26 percent of patients with rosacea also had facial seborrheic dermatitis and 28 percent had seborrheic dermatitis of the scalp. Additionally, a survey by the National Rosacea Society of 1,100 rosacea patients found that 25 percent had also been diagnosed with this condition.

…

When seborrheic dermatitis appears with rosacea, a safe and effective antifungal alone may often be prescribed because the long-term use of topical steroids is associated with rosacea-like symptoms. This condition is known as steroid-induced rosacea. Treatment of seborrheic dermatitis of the scalp may include medicated anti-dandruff shampoos.

Rosacea patients who suspect they may have this disorder are urged to see a dermatologist for diagnosis and appropriate treatment.

Nothing too ground breaking, but it is good to see the NRS writing about SD as it is so common for rosacea sufferers.

Related Articles

• Sebclair for seborrheic dermatitis
• Malassezia Globosa causes seborrhea, Pyrithione Zinc is effective
• Xolegel for treating seborrheic dermatitis (seb derm)
• cleansing your SD skin with a sonic brush (Clarisonic)
• seb derm, elidel and protopic : a warning
• sebazole (topical ketoconazole gel 2%) low systemic absorption for short treatment periods

Metronidazole 0.75% gel vs. ketoconazole 2% cream in the treatment of facial seborrheic dermatitis: a randomized, double-blind study, D Seckin, O Gurbuz, O Akin, JEADV, Volume 21 Issue 3 Page 345-350, March 2007.

Background: Recently, two placebo-controlled studies have shown that topical metronidazole was effective in the treatment of seborrheic dermatitis.

Objective: To compare the efficacy and safety of metronidazole 0.75% gel with that of ketoconazole 2% cream in the treatment of facial seborrheic dermatitis.

Methods: A total of 60 consecutive patients with facial seborrheic dermatitis were included. Patients were randomized into two groups. One group used ketoconazole 2% cream with metronidazole gel as vehicle; the other group used metronidazole 0.75% gel with ketoconazole cream as vehicle for a 4-week treatment period. Main outcome measures were change in clinical severity scores, patients’ and investigator’s global evaluation of improvement and frequency of side-effects.

Results: All the assessments were made by an investigator who was unaware of which group the patients were allocated to. Mean percentage decrease in clinical severity scores from baseline to last available visit was 63.4% (95% CI 57.7–69) and 54.4% (95% CI 47.9–61) in the ketoconazole- and metronidazoletreated patients, respectively (P = 0.31). Eighty-two per cent of patients in the ketoconazole group vs. 79% of patients in the metronidazole group rated their global improvement as significant or moderate (P > 0.05). No statistically significant difference in the frequency of side-effects was detected between the two groups. The results of this study need to be confirmed in further studies involving large numbers of patients.

Conclusion: Our data demonstrated that metronidazole 0.75% gel had a comparable efficacy and safety profile with that of ketoconazole 2% cream in the treatment of facial seborrheic dermatitis.

Related Articles

• Sebclair for seborrheic dermatitis
• Malassezia Globosa causes seborrhea, Pyrithione Zinc is effective

This product sounds quite interesting for rosacea and rosacea/SD sufferers. Little information about Sebclair is currently available on the internet.

Sebclair (MAS064D) is approved for use in the European Union to treat seborrheic dermatitis. One of Sebclair’s claim to fame is that it contains no corticosteroids or immunomodulating agents. The paper’s authors admit that it is difficult to know which compound is responsible for Sebclair’s success as a treatment.

The authors state “We believe that the major activity is probably due to the synergistic effect of both piroctone olamine, for its antimycotic action, and glycyrrhetinic acid, for its anti-inflammatory action.”

Sebclair Ingredients

The following descriptions of each ingredient is supplied in the full text of the paper.

Alglycera is a compound combining the anti-inflammatory properties of glycyrrhetinic acid and the keratolytic properties of allantoin.

Glycyrrhetinic acid, extracted from the licorice root, exhibits anti-inflammatory properties in different organs in several animal models,
with a potency similar to that of indomethacine. Its chemical structure is similar to that of cortisone and has been shown to potentiate the action of hydrocortisone

Piroctone olamine is an antimycotic effective against Malassezia spp.

The standardized extract of V. vinifera (grapevine) in Sebclair contains 40% of epigallocatechin gallate, a proanthocyanidine that prevents oxidative damage to the endothelium, with maintenance of optimal blood supply. It works as an antioxidant synergistically with telmesteine and Vitamin E.

Shea butter, from Butyrospermum parkii, is composed of tryglycerides and fatty acids, including linoleic acid, rich in phytosterols and tocopherols. The action of shea butter is enhanced by isohexedecane, another emollient present in the formulation.

If you live in the EU and suffer from SD, please do let us know how you like Sebclair, but leaving a comment below.

Treatment of mild to moderate seborrhoeic dermatitis with MAS064D (Sebclair), a novel topical medical device: results of a pilot, randomized, double-blind, controlled trial, J Eur Acad Dermatol Venereol. 2008 Mar;22(3):290-6. S Veraldi, A Menter, M Innocenti, Institute of Dermatological Sciences, University of Milan, IRCCS Foundation, Policlinico, Mangiagalli and Regina Elena Hospital, Milan, Italy; Baylor University Medical Centre, Dallas, TX, USA, European Institute of Dermatology, Milan, Italy

Aim: MAS064D (Sebclair) is a novel steroid-free cream containing multiple active ingredients. Objective of this pilot study was to evaluate the efficacy and safety of MAS064D in the treatment of mild to moderate SD of the face.
Methods: Patients (n= 60) with SD were randomized to receive MAS064D (n= 40) or a matching vehicle (n = 20). The primary study endpoint was investigators’ global assessment (IGA) score at day 28, compared with baseline. Secondary endpoints included: IGA score at day 14; investigators’ assessment of erythema and scaling; patients’ assessment of burning/stinging, pruritus and global response to MAS064D; resort to rescue medication; quality of life.
Results: Use of MAS064D for 4 weeks was associated with a higher percentage of success in the MAS064D group than in the vehicle group (~68% vs 11%, P < 0.0001). The effects of MAS064D were significantly better than those of vehicle for investigator-assessed erythema and scaling, and patients’ assessed pruritus and global response to MAS064D (P ≤ 0.01). No patient in the MAS064D
group required rescue medication, compared with two patients in the vehicle group. Four patients (two each in the MAS064D and vehicle groups) reported a total of six non-serious adverse events.
Conclusions: MAS064D appears to be an effective and well tolerated cream for the treatment of mild to moderate SD of the face. Further clinical evaluation of MAS064D in SD is warranted.

Update: Sebclair has launched as Promiseb Cream in the United States.

Sinclair Pharma: Sebclair

Related Articles

• Malassezia Globosa causes seborrhea, Pyrithione Zinc is effective
• Xolegel for treating seborrheic dermatitis (seb derm)
• treating seborrheic dermatitis with itraconazole (sporanox)
• Sebclair / Atopiclair available in Australia

With the recent push by Clarisonic to promote their sonic brush as treatment for rosacea, I thought it might be interesting to see some reviews of users of the Clarisonic Skin Care System by rosacea sufferers. Although it is expensive, it does seem to be working quite well and so far no-one is reporting that it has irritated their skin. This is a bit of a surprise to me, that it is seemingly so well tolerated.

If you try it, please do let us know what you think. Leave a comment at the end of this post.

Yvette on Tue 10 Apr 2007 said,

I bought the Clarisonic brush about a week or two ago. I was nervous to use it at first because I did see conflicting notes about whether it’s okay for Rosacea. On the Clarisonic website it does have some pic’s for those with Rosacea and mild acne and that it’s okay to use. However, in the brochure that comes with the Clarisonic, it stated, if you have a skin condition (which Rosacea and acne are especially named) ask your health care professional before use.

I asked my Derm’s office (P.A.) and she hadn’t heard of it. Even my aesthetician hadn’t heard of it. Both my Derm. and aesthetician said to be cautious and don’t be over zealous with it. The brush comes with a sensitive brush and a normal skin brush. It says you can use twice a day. I’ve used only once a day, mainly in the morning, and it does seem to do a better job cleansing my skin versus by hand. The sensitive brush is very soft and doesn’t irritate. If I have a pimple (one with fluid) I avoid brushing. I wouldn’t recommend at all if you have active acne or pustular bumps; if pimples somehow pop while using the brush the germs will get on the brush and you can carry them to other areas of the face and more acne could result. Overall, my face is MUCH softer and cleaner after use. After I clean my face with the Clarisonic, I give my face several splashes of water. I rinse the brush in hot water each time and deep clean (in antibacterial soap) every few days. Over the past week, the texture of my skin has improved and my pores are cleaner. I don’t have any increased redness or irritation. My makeup goes on better and lasts longer too.

I just want to add the sensitive brush is very soft and when used it feels like a soft plushy towel is cleaning your face. Previously, I washed using my hands, but found sometimes my face wasn’t really clean. The brush bristles move in circular oscillating motions to work “with your skin” versus pulling it. The slight bumps (probably clogged pores) I had on my jaw line a few weeks ago are nearly gone. My face is definitely smoother and I have less bumps and clogged pores. I still get a few breakouts on my chin and try to avoid using the Clarisonic on this area until healed. When using, I use a very gentle non-soap cleanser (MD Forte non soap cleanser or Christine Chin sulfate free Ultra Calming Gel cleanser).

rosesarered on Sat 14 Apr 2007 said,

At any rate, it continues to seem to improve my skin pretty dramatically. I’ll say just briefly what my own skin is like, in the hopes that that might help others considering Clarisonic decide whether it’d be right for them. I have dry, dry skin with tiny flakes on my cheeks and nose. I have enlarged pores on my cheeks, and some permanent redness, accompanied by occasional flushes. In the past, my skin has responded favourably to exfoliants like Pond’s Purely Polished when VERY gently, carefully, and infrequently applied. My skin’s response to the exfoliant was one of the things that made me optimistic about Clarisonic, which seemed like a much gentler and chemical-free way to accomplish the same ends.

az21300 said on Fri 25 May 2007

I have been using the clarisonic brush for about a month and a half now. its amazing. it comes with a sensitive brush and and normal brush. i have now worked my way up to the normal brush and my skin is loving it. I use it twice a day with a CVS version of cetaphil. i find that my skin is about 2X’s as smooth as it was prior. it obviously hasn’t cured my rosacea but has helped a lot…

sprtmrg said on 24 Feb 2007,

I’ve tried it and found it to be very helpful. A spa I went to recommended it to me. At first I was not interested because I thought it would be too harsh for my sensitive skin. They had a whole box of of the delicate (blue) brush heads that they had gotten from the rep. They let me use their system with a new brush head to try it out and see if I liked it. My skin felt baby soft and smooth afterward.
I purchased the system in November for $150. They gave me a free blue brush head. The system comes with both white and gray but the blue is the most delicate. When you buy the system you also get a free one year subscription to Health magazine and a coupon good for two free brush heads, plus a coupon for a buy one get one brush head. I called the company and asked if I could get the blue and they said okay. The brush heads are $25 each full price. My skin type is oily with large pores and I tend to get a little bit of seb derm. I also get what seems like little bits of sand stuck inside my pores (chicken skin). This works miracles for that. My skin is softer and smoother and I’ve been using it since November. The seb derm is also gone and the machine has never made me turn red. Many things do but not the Clarisonic. The difference in the skin is like the difference between brushing your teeth or using one of those electric toothbrush systems (I use the Braun).

During this time I’ve been undergoing laser genesis treatments. If your doctor’s office has one you might be able to get a good deal. I hear Nordstrom sells the machines too and they have a very good return policy. I would think anyone with oily skin could give this a try but maybe those with very dry skin might need to be more careful. I’m not in any way affiliated with Clarisonic or get any type of benefit for promoting their product. I’ve tried so many things out there and this really seems to work for me. I hope this can help someone else too.

Featured Product

Related Articles

• using a sonic brush to treat rosacea and seb derm
• Clairsonic Skin Care System
• cleansing and the management of rosacea
• mild cleanser is important
• Sensitive Skin Products for Rosacea Sufferers

Some great links to heaps more information and the ongoing discussion here ;

• Rosacea Support Forum: Real cause of seborrhea discovered!
• Rosacea Support Forum: Seb Derm & Rosacea Studies?

I thought this patent was interesting because it deals with something that I hadn’t heard of before, but seems like it might have some potential. This patent application makes me wonder if we will see anything else interesting done with acerola seed.

Acerola seed comes from a fruit that is high in vitamin C. We can see from patent application 20060051439 that "extract of acerola seeds has strong antioxidative capability, collagenase inhibitory effect, and hyaluronidase inhibitory effect,".

The patent application 20070286915 looks potentially interesting for rosacea sufferers with nerve mediated pain, itching or dermatits. Nerve growth factor production inhibitor and external preparation for the skin, cosmetic, quasi drug, preventive and remedy for atopic dermatitis containing the nerve growth factor production inhibitor

in a recent research, transfer fiber terminal (C fiber terminal) of the itching, of which existence is recognized only to the boundary of epidermis and dermis in healthy skin, extends to epidermis of skin having atopic dermatitis or dried skin. In this respect, it is pointed out that the extension of the C fiber terminal to epidermis is a cause of intense itching in senile pruritus, atopic dermatitis and dried skin.

…

the present inventors have found that an acerola seed extract has an excellent nerve growth factor production inhibition function, especially, it eases and improves an inflammation or an itching produced in skin and is safe for a living body.

…

it is possible to directly remove the cause of the itching by inhibiting the production of NGF which is the nerve growth factor deeply involved with the extension of C fiber to epidermis. In addition, it is possible to provide the nerve growth factor production inhibitor with high safety, as well as the external preparation for the skin, cosmetic, and the like containing the nerve growth factor production inhibitor.

Related Articles:

• Patents abound for treating rosacea with alpha agonists
• patent: ocular rosacea and `acne rosacea’ treated together
• FDA approves Lyrica for Fibromyalgia

Anti-inflammatory effects of ketoconazole: Clinical benefits in the treatment of seborrheic dermatitis, Lieve Vandeplassche, Barrier Therapeutics, Princeton, NJ, United States

Seborrheic dermatitis is a common inflammatory skin disorder characterized by a red, scaly, itchy rash on the scalp, face, and trunk. Topical ketoconazole has been in the armamentarium for the treatment of seborrheic dermatitis for decades. Topical ketoconazole formulations have demonstrated efficacy in clinical trials, and therapeutic benefits were attributed to its reduction in the number of Malassezia furfur (Pityrosporum ovale) cells. It was believed that this antimycotic effect was responsible for the reduced inflammation observed in patients with seborrheic dermatitis who received treatment. While this mechanism of action is sound, additional possible mechanisms have emerged. In a murine gene activation study, ketoconazole reduced LPS-induced increase in enzyme iNOS mRNA activation by ~50%. This reduction in gene expression and consequent inhibition of reactive radical nitric oxide production supports another mechanism for the anti-inflammatory effect of ketoconazole. This may explain the antierythema and antiedema action of the compound. A study in test animals found that topical ketoconazole had anti nflammatory activity against the erythema and hyperkeratosis induced by the application of killed Staphylococcus aureus and was comparable to the effects of steroid therapy.

Recent findings are also being evaluated which may further demonstrate the anti inflammatory properties of ketoconazole. Specifically, data on ketoconazole USP 2% gel, a novel formulation that utilizes a unique transdermal delivery medium appears to support such activity. A double-blind study evaluating cumulative irritation potential over a 21-day period found that ketoconazole USP 2% gel was less irritating than its topical gel vehicle. In a separate supportive phase 3 study ketoconazole USP 2% gel provided comparable improvement in signs and symptoms scores to a combination of ketoconazole and the steroid desonide in the treatment of seborrheic dermatitis. In conclusion, the efficacy of ketoconazole may be supported by its anti inflammatory properties, a key factor in the treatment of seborrheic dermatitis. These anti inflammatory effects have been attributed to the antimycotic activity of ketoconazole, but growing data suggest that other mechanisms may also be responsible.

100% is sponsored by Barrier Therapeutics.

Poster Abstract P807, American Academy of Dermatology, 65th Annual Meeting February 2-6, 2007, Washington, DC. Published in Journal of the American Academy of Dermatology Volume 56, Number 2.

Further Reading ;

• product web site for Xolegel and the Xolegel Prescribing Information
• sebazole (topical ketoconazole gel 2%) low systemic absorption for short treament periods
• topical 2% ketoconazole warnings for long term usage
• itraconazole and treating seb derm
• seb derm, elidel and protopic : a warning
• Seborrheic Dermatitis ketoconazole nizoral shampoo