Browsing by Author "Stein Gold, Linda"

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    Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug
    (Springer, 2022) Stein Gold, Linda; Baldwin, Hilary; Kircik, Leon H.; Weiss, Jonathan S.; Pariser, David M.; Callender, Valerie; Lain, Edward; Gold, Michael; Beer, Kenneth; Draelos, Zoe; Sadick, Neil; Pillai, Radhakrishnan; Bhatt, Varsha; Tanghetti, Emil A.; Dermatology, School of Medicine
    Background: A three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance. Objectives: We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne. Methods: In a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed. Results: A total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8-30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6-26.8; noninflammatory, 21.8-30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity. Conclusions: Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne.
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    The association between obesity and efficacy of psoriasis therapies: An expert consensus panel
    (Elsevier, 2024) Burshtein, Joshua; Armstrong, April; Chow, May; DeBusk, Lauren; Glick, Brad; Gottlieb, Alice B.; Stein Gold, Linda; Korman, Neil J.; Lio, Peter; Merola, Joseph; Rosmarin, David; Rosenberg, Angela; Van Voorhees, Abby; Lebwohl, Mark; Dermatology, School of Medicine
    Background Psoriasis is a chronic inflammatory skin disease often associated with obesity. Psoriasis therapies may be less effective in patients with obese. The purpose of this expert consensus panel is to evaluate the relationship between obesity and efficacy of psoriasis therapies, thereby optimizing patient care. Methods A comprehensive literature search was completed on July 19, 2024, using the keywords “psoriasis,” “obesity,” “efficacy,” “treatments,” and “therapies.” A panel of 11 dermatologists with significant expertise in treatment of psoriasis gathered to review the articles and create consensus statements. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned. Results The literature search produced 500 articles. A screening of the studies resulted in 22 articles that met criteria. The panel unanimously voted to adopt 10 consensus statements and recommendations, 6 were given a strength of “A,” 2 were given a strength of “B,” and 2 were given a strength of “C.” Conclusion Psoriasis and obesity have a strong association. Obesity decreases efficacy of biologics and may decrease efficacy and potentiate side effects of conventional therapies. It also impacts drug survival. Weight control is a vital component of caring for patients with psoriasis and the number of therapeutic options available is rising.