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Background

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.

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Background

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  1. 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.

  2. 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

  3. 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

  4. Discussion of Results • ITT population 34 subjects • 18applied drug on> 75% BSA • 16 applied drug on 50-75% of BSA • Approximate drug used per day: 9.5 + 4.7 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)

  5. Solomon JR: Pediatric burns. Crit Care Clin 1:159-174, 1985

  6. After 4 Weeks of Treatment (N=21) Study 1 Week 0 vs. Week 4 p = value* At Start of Study (N=21) *Pooled data for 4 centers

  7. After 4 Weeks of Treatment (N=13) Study 2 Week 0 vs. Week 4 p = value* At Start of Study (N=13) *p-value from paired t-test 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

  8. 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.

  9. 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 -- nochange in morning baseline value of plasma Cortisol, nor did it affect Cortisol stimulation by administration of ACTH.

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

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