Background Derma-Smoothe/FS ® (Fluocinolone acetonide ) Contains 0.01% fluocinolone acetonide in an oil base solution, Categorized as a low to medium potency.

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Presentation transcript:

Background Derma-Smoothe/FS ® (Fluocinolone acetonide ) Contains 0.01% fluocinolone acetonide in an oil base solution, Categorized as a low to medium potency corticosteroid preparation. Two independent open-label safety studies were conducted to assess the adrenal (HPA axis) suppression potential of Derma-Smoothe/FS ®, in children 2 to 12 years of age, with moderate to severe atopic dermatitis. Derma-Smoothe/FS ® was approved for pediatric indication based on these safety studies and well-controlled clinical efficacy studies.

Study Design Multi-center, open-label safety studies for the treatment of atopic dermatitis (eczema) Patient criteria: Moderate to severe atopic dermatitis involving greater than 50% of the total body surface area (BSA) Dosage and duration of treatment: Twice daily application on diseased skin; continuous treatment for 4 weeks Criteria for (Safety) evaluation: Cosyntropin (ACTH) stimulation test Serum Cortisol levels, baseline and post stimulation

Study Design (continued) Day 1 prior to first treatment, and at Day 29 after last treatment: Pre-stimulation serum Cortisol level (baseline) assessment Immediately followed by stimulation with Cosyntropin test (intravenous) Post-stimulation serum Cortisol level (after 60 minutes) Data was compared using the paired t-test

Discussion of Results ITT population 34 subjects 18 applied drug on > 75% BSA 16 applied drug on 50-75% of BSA Approximate drug used per day: mL/day Baseline Cortisol levels did not change from Day 1 to Day 29 (Study 1, p=0.622) (Study 2, p=0.376) Increase in Cortisol levels after stimulation was not significantly different from Day 1 to Day 29 (Study 1, p=0.296) (Study 2, p=0.647)

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Cortisol Concentration at Baseline Increase in Cortisol After Stimulation At Start of Study (N=21) After 4 Weeks of Treatment (N=21) Week 0 vs. Week 4 p = value* *Pooled data for 4 centers Study 1

Cortisol Concentration at Baseline Increase in Cortisol After Stimulation At Start of Study (N=13) After 4 Weeks of Treatment (N=13) Week 0 vs. Week 4 p = value* *p-value from paired t-test Study 2 Reference range for Cortisol values : 3.4 – 26.9 µg/dL ACTH stimulation test criterion for normal response at 60 minutes: approximate doubling of the basal plasma cortisol value

Example of drug exposure estimation 4 fl oz bottle of Derma-Smoothe/FS ® contains 12mg of fluocinolone acetonide (FA) Ave. daily dose of 9.5mL of Derma-Smoothe/FS ® ~ 1mg of FA Note: 1-2% corticosteroid is absorbed topically Based on a 1-2% absorption, the total FA absorbed is 0.02mg/day Reference: (H.I Maibach, Ch. Surber, Topical Corticosteroids, 1992; 165, 199, 201 Comparative quantitative studies utilized in the FDA diseased-skin protocol demonstrate that as little as 14 g/week of clobetasol propionate may induce suppression, and over 49 g/week of betamethasone dipropionate is required to significantly reduce plasma cortisol levels.

Conclusion Four weeks twice daily application of Derma-Smoothe/FS ® (fluocinolone acetonide 0.01%) to diseased skin involving over 50 to 90% of body surface area -- no change in morning baseline value of plasma Cortisol, nor did it affect Cortisol stimulation by administration of ACTH.

Efficacy results after 4 weeks treatment showed excellent or better (75% to 100%) improvement in more than 60% of the subjects.