Following are two presentations from the American Academy of Dermatology, 64th Annual Meeting, March 3-7 2006, San Francisco. Metrogel 1% was in full promotional mode during this time. Naturally enough Galderma are keen to promote the 1% formulation of metrogel as this is seen as a `new’ product since the 0.75% version has come out of patent.

Efficacy and safety of metronidazole gel 1% compared to azelaic acid 15% in the treatment of rosacea: A phase IIIB study

John Wolf, MD, Baylor College of Medicine, Houston, TX, United States

Rosacea is a common, chronic dermatosis characterized by the presence of facial erythema, visible blood vessels, and papules and pustules. With the face being the predominant site of involvement, this disease is often associated with serious psychosocial morbidity and can significantly impact quality of life. It is of paramount importance that the dermatology community continues to investigate and advance the treatment of this disease. Metronidazole and azelaic acid currently represent two medications indicated for the treatment of rosacea. Recently, metronidazole was made available in a new gel formulation at a higher concentration (1% metronidazole).

This new formulation has been shown to be very tolerable and nonirritating despite the higher concentration of metronidazole. A phase IIIB study was therefore conducted to compare the 1% metronidazole gel to azelaic acid gel 15% for the treatment of moderate rosacea. This was a randomized, multicenter, investigatorblinded, parallel comparison study that enrolled 160 patients among 15 sites.

Patients were randomized to treatment with either once-daily metronidazole gel or twice-daily azelaic acid gel per product use instructions. Subjects were evaluated at baseline and at 3-week intervals for the duration of the 15-week study. Evaluations included lesion counts, erythema severity and investigator’s global severity. The efficacy of metronidazole 1% gel compared to azelaic acid gel 15% will be presented along with safety and tolerability data.

This is the first study of this kind to compare metronidazole 1% gel to azelaic acid gel 15% in rosacea patients. The results of this study are expected to provide valuable information to dermatologists choosing a treatment regimen for their rosacea patients.

Author disclosure: Nothing disclosed at press time. Study and poster support provided by Galderma Laboratories, L.P.

Poster Discussion Session P562, American Academy of Dermatology, 64th Annual Meeting, March 3-7 2006, San Francisco.

Supplement to Journal of The American Academy of Dermatology, March 2006, Volume 54, Number 3.

• JAAD Poster Abstracts Online
• focus on finacea (azelaic acid 15%)
• focus on metrogel
• 1 percent metrogel from galderma
• generic metrogel soon – Fougera

Metronidazole 1% gel for the treatment of rosacea patients

Joseph Bikowski, MD, Sewickley, PA, United States

Rosacea is a chronic and recurrent inflammatory dermatological disorder of unknown etiology, commonly affecting fair-skinned people amounting to approximately 14 million adults and 3 times more women than men in the United States alone. Progression of the disease can be associated with erythema and telangiectasia with progression to inflammatory papules and pustules, with more severe cases involving tender painful nodules and tissue hypertrophy such as rhinophyma. Successful management of rosacea involves the avoidance of trigger factors in combination with pharmaceutical agents, including both systemic and topical therapies.

Topical metronidazole is a proven therapy for the treatment of rosacea and its efficacy has been well confirmed. A new formulation of metronidazole makes possible the solubilization of 1% metronidazole in a cosmetically-acceptable gel. This gel formulation has been shown to be nonirritating and preserves the integrity of the skin barrier despite the higher concentration of metronidazole than what was previously possible in a gel.

This new metronidazole 1% gel has recently been approved by the FDA for the treatment of rosacea.

Reported herein are representative case studies of patients who presented with rosacea and were either untreated or dissatisfied with their current rosacea regimen. Photographic assessments were made at baseline and at 2, 4, and 8 weeks after once-daily treatment with metronidazole 1% gel. In addition, efficacy and tolerability assessments were made.

Representative photographs and discussion of treatment results will be presented to help clarify the utility of this new treatment option available to dermatologists treating rosacea.

Author disclosure: Nothing disclosed at press time. Study and poster supported by Galderma Laboratories, L.P.

Poster Discussion Session P579, American Academy of Dermatology, 64th Annual Meeting, March 3-7 2006, San Francisco.

Supplement to Journal of The American Academy of Dermatology, March 2006, Volume 54, Number 3.

• JAAD Poster Abstracts Online
• focus on finacea (azelaic acid 15%)
• focus on metrogel
• 1 percent metrogel from galderma
• generic metrogel soon – Fougera