Novel Polymeric Lotion Formulation of Once-Daily Tazarotene (0.045%) for Moderate-to-Severe Acne: Pooled Phase 3 Analysis
| Autor: | Eric Guenin, Susan Harris, Emil Tanghetti, Radhakrishnan Pillai, Edward Lain, William Philip Werschler, Anya Loncaric |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Moderate to severe medicine.medical_specialty Adolescent Polymers Skin Cream Pain medicine.disease_cause Severity of Illness Index Young Adult Keratolytic Agents Double-Blind Method Tazarotene Acne Vulgaris medicine Humans Child Adverse effect Acne Aged Randomized Controlled Trials as Topic business.industry Nicotinic Acids General Medicine Middle Aged medicine.disease Dermatology Treatment Outcome Clinical Trials Phase III as Topic Tolerability Lotion Quality of Life Emulsions Female Once daily Irritation business medicine.drug |
| Zdroj: | Journal of Drugs in Dermatology. 19:272-279 |
| ISSN: | 1545-9616 |
| DOI: | 10.36849/jdd.2020.4869 |
| Popis: | Background: As current tazarotene formulations indicated for acne (0.1%) can cause irritation, a new tazarotene 0.045% lotion formu-lation was developed using polymeric emulsion technology. The objective was to assess efficacy, safety, and tolerability of tazarotene 0.045% lotion in patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies. Methods: Patients aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion applied once daily. Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS) were assessed. Treatment success was defined as a ≥2-grade improvement in EGSS and a score of 'clear'/'almost clear'. Adverse events (AEs) and cutaneous safety and tolerability were also assessed. Results: In total, 1614 patients (mean age: 20.5 years) were randomized to tazarotene 0.045% lotion (n=799) or vehicle (n=815). At week 12, tazarotene 0.045% lotion demonstrated statistically significant superiority versus vehicle in reducing inflammatory and non-inflammatory lesion counts (least-squares mean percent changes from baseline: inflammatory, -57.9% vs -47.8% [P |
| Databáze: | OpenAIRE |
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