Angela Y. Moore M.D.

Raoof, T. J., D. Hooper, A. Moore, M. Zaiac, T. Sullivan, L. Kircik, E. Lain, J. Jankicevic and I. Stuart (2019). “Efficacy and Safety of a Novel Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: A Phase 3 Study.” J Am Acad Dermatol Jun 1. [Epub ahead of print].

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BACKGROUND: FMX101 4% topical minocycline foam, has been demonstrated as an effective and safe treatment for acne vulgaris. OBJECTIVE: Further evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe AV. METHODS: A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Co-primary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (IGA score: 0 or 1 with a greater-than-or-equal-to 2-grade improvement). RESULTS: 1488 subjects were in the intent-to-treat population. FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P<.0001) and a greater rate of IGA treatment success (P<.0001) vs foam vehicle group at week 12. FMX101 4% was generally safe and well-tolerated. LIMITATIONS: Efficacy and safety of FMX101 4% was not characterized in subjects with mild AV. CONCLUSION: FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate-to-severe AV.

Bagel, J., K. C. Duffin, A. Moore, L. K. Ferris, K. Siu, J. Steadman, F. Kianifard, J. Nyirady and M. Lebwohl (2017). “The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study.” J Am Acad Dermatol 77(4): 667-674.

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BACKGROUND: Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. OBJECTIVE: Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. METHODS: In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. RESULTS: At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator’s Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies. LIMITATIONS: There was no active comparator arm. CONCLUSION: Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.

Bagel, J., K. C. Duffin, A. Moore, L. K. Ferris, K. Siu, J. Steadman, F. Kianifard, J. Nyirady and M. Lebwohl (2017). “The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study.” J Am Acad Dermatol: 2017 Aug [Epub ahead of print].

Full text of this article.

BACKGROUND: Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. OBJECTIVE: Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. METHODS: In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. RESULTS: At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator’s Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies. LIMITATIONS: There was no active comparator arm. CONCLUSION: Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.