Efficacy and safety comparison of combination of 0.04% tretinoin microspheres plus 1% clindamycin versus their monotherapy in patients with acne vulgaris: a phase 3, randomized, double-blind study
| Autor: | Amey Mane, C Nayak, P P Vaidya, Sunil Dogra, T K Sumathy, Rajan Mittal, G Ravichandran, Suyog Mehta, Sujeet Narayan Charugulla |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Tretinoin Dermatology Microsphere Unmet needs Double blind study 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Acne Vulgaris medicine Humans In patient Acne 030203 arthritis & rheumatology business.industry Clindamycin medicine.disease Microspheres Drug Combinations Treatment Outcome Tolerability business Gels medicine.drug |
| DOI: | 10.6084/m9.figshare.11807172 |
| Popis: | Background and objectives: There is an unmet need for topical treatments with good tolerability in management of acne vulgaris. The present study aimed to evaluate efficacy and safety of a novel tretinoin (microsphere, 0.04%) formulation in combination with clindamycin (1%) gel for treatment of acne vulgaris. Materials and methods: This phase 3 randomized, double-blind study included patients with moderate-to-severe acne. Patients were treated with tretinoin (microsphere, 0.04%) + clindamycin (1%) or one of the monotherapies (tretinoin, 0.025%; clindamycin, 1%). Key endpoints included percent change in lesion counts, and improvement in Investigator���s Static Global Assessment (ISGA) score. Results: 750 patients were randomized (combination, n = 300; tretinoin and clindamycin, each n = 150). At week 12, reductions in inflammatory (77%), non-inflammatory (71%) and total lesions (73%) were significantly greater with combination treatment versus either monotherapy (p p Conclusion: The once-daily, microsphere-based formulation was generally tolerable with a positive impact on therapeutic outcomes and patients��� compliance. ClinicalTrial Registration No.: CTRI/2014/08/004830 |
| Databáze: | OpenAIRE |
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