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    Ciclopiroxolamine cream 1 percent useful for facial seborrheic dermatitis

    Paris - Topical 1 percent ciclopiroxolamine cream is a safe and effective treatment for mild-to-moderate facial seborrheic dermatitis, according to research presented at the World Congress of Dermatology.

    Olivier Chosidow, M.D., Ph.D., professor of dermatology and therapeutics, department of internal medicine, Hopital Pitie-Salpetriere, Paris, France, presented results from two multicenter, randomized studies supporting the conclusion. The first was a double-blind trial enrolling 129 patients and demonstrating the superiority of the antifungal cream against vehicle control. As a follow-up, a second open-label, active comparator trial was undertaken. It included over 300 subjects and showed the outcomes achieved with ciclopiroxolamine cream compared favorably against ketoconazole 2 percent foaming gel.

    "On a theoretical basis, ciclopiroxolamine is a rational choice for treatment of seborrheic dermatitis because it offers good antifungal potency against Pityrosporum ovale and also has anti-inflammatory activity, which is probably secondary to inhibition of arachidonic acid metabolism via the lipoxygenase pathway. The results of these studies confirm its efficacy, show that the topical cream is well tolerated, and indicate that it is a worthwhile addition to the possible treatments for patients with mild-to-moderate facial seborrheic dermatitis," Dr. Chosidow said.

    In the vehicle-controlled trial, treatment with the antifungal cream and its matched vehicle was initiated twice daily for up to 28 days; thereafter, patients entered a four-week maintenance phase during which the frequency of application was reduced to once a day. The same application regimen was used for ciclopiroxolamine in the open-label study, whereas patients assigned to ketoconazole were instructed to use the foaming gel twice a week for the first 28 days of treatment followed by once a week over the next 28 days.

    Efficacy in both trials was assessed as "treatment response," which was defined according to stringent criteria that required complete disappearance of erythema and scaling associated with lesions in the nasolabial folds and/or eyebrow region. In the ketoconazole-controlled trial, resolution of pruritus was also necessary.

    After the first 28 days of treatment, the proportion of treatment responders was significant and about three-fold higher among patients using ciclopiroxolamine cream 1 percent compared with vehicle, 44 percent vs. 15 percent, respectively. Some patients achieved benefit from extending the duration of treatment duration, and treatment response rates increased in both groups at study completion, reaching 63 percent for ciclopiroxolamine-treated patients and 34 percent for the controls. However, the difference in efficacy remained highly statistically significant favoring ciclopiroxolamine.

    After 28 days in the open-label trial, the rate of response to ciclopiroxolamine was 37 percent compared with 34 percent among patients using ketoconazole. By study end, a significantly higher proportion of patients using ciclopiroxolamine achieved treatment response compared with the ketoconazole group, 57.5 vs. 44 percent.

    Disease affecting other facial regions was also treated, and while the response at those sites was not considered in the primary outcome assessment, a total lesional score was calculated that included ratings of erythema, scaling, and functional signs (burning, itching) for all facial lesions. In the placebo-controlled trial, the mean total lesional score decreased from 9.91 at baseline to 2.85 after 28 days and 0.91 at study completion in the ciclopiroxolamine group. More than three-fourths of active-drug patients rated efficacy as "very satisfactory" or "satisfactory."

    In both trials, the ciclopiroxolamine cream was very well tolerated. No patients discontinued the ciclopiroxolamine due to adverse reactions, and some advantages were noted for ciclopiroxolamine in the safety analyses. In the vehicle-controlled study, about 75 percent of patients rated ciclopiroxolamine as "satisfactory" or better with regard to tolerance and ease of use, and significantly fewer patients using ciclopiroxolamine developed local adverse events compared with the vehicle group, 33 percent vs. 50 percent, respectively. That difference was primarily due to a significantly lower proportion of patients developing lesional aggravation with ciclopiroxolamine vs. vehicle, 17 percent vs. 33 percent, respectively.

    In the active comparator trial, there were significant differences favoring ciclopiroxolamine cream vs. ketoconazole in analyses of local tolerance and global acceptability.

    "The data showing better tolerance for ciclopiroxolamine compared with ketoconazole must be interpreted carefully considering the potential for bias in this open-label trial and the difficulty in discriminating between signs and symptoms of unresponsive disease and drug-induced local irritation. Importantly, however, the ciclopiroxolamine cream has been associated with good safety and patient acceptance, and those are key features for drugs used to treat seborrheic dermatitis considering the chronic and recurring nature of that disease," Dr. Chosidow said.

    As caveats, he added that the efficacy of ongoing maintenance treatment with ciclopiroxolamine for preventing relapse remains to be determined through further studies. In addition, he noted that seborrheic dermatitis patients exhibiting more severe inflammation may not be as good candidates for monotherapy with any antimycotic agent. In his own practice, Dr. Chosidow said he will initiate treatment of such cases with a topical corticosteroid for several days and start the antifungal drug only after the inflammation has lessened.

    "In the original protocol for the placebo-controlled trial, patients with more severe inflammation were eligible for enrollment. However, we learned quickly that those individuals did not respond as well, and thereafter, we entered patients with only mild to moderate disease," he said.

    Patient eligibility for the trials was determined by assessment of erythema and scaling on baseline digital photographs. Investigators were carefully trained before the study was launched to ensure good inter-rater consistency in determining the severity of those signs. Erythema and scaling were rated on a scale of 0 (absent) to 3 (severe), and only patients with an erythema score of 2 or less but with a total score of at least 3 were entered.

    The product is produced by Pierre-Fabre Dermatology, Castres, France and recently received approval for treatment of facial seborrheic dermatitis. Dr. Chosidow was coordinator for the Phase IV studies and consultant to Pierre-Fabre.

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