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A new study published in The Journal of Dermatological Treatment evaluated the efficacy and safety of a novel tretinoin (microsphere, 0.04%) formulation in combination with clindamycin (1%) gel for treatment of acne vulgaris.
This was a phase III randomized, double-blinded trial that included patients with moderate-to-severe acne. Patients were treated with tretinoin (microsphere, 0.04%) + clindamycin (1%) or either of the monotherapies – tretinoin, 0.025% or clindamycin, 1%. Outcomes included percent change in lesion counts and improvement in Investigator’s Static Global Assessment (ISGA) score.
Overall, 750 patients were randomized – combination, n = 300; tretinoin+ clindamycin; each, n = 150. It was observed thatafter 12 weeks of these interventions, reductions in inflammatory (77%), non-inflammatory (71%) and total lesions (73%) were significantly greater with combination treatment versus either of the monotherapies. Proportion of patients rated ‘clear’ or ‘almost clear’ with ≥2-grade ISGA improvement was higher with combination than with the monotherapies. Adverse events occurred in 20 patients, but most were mild-moderate with no deaths or serious adverse events reported. While the discontinuation rates due to adverse events with combination therapy were low (≤1%).
Hence, theonce-daily, microsphere-based formulation was generally tolerable with a positive impact on therapeutic outcomes and patients’ compliance.
Source: The Journal of Dermatological Treatment. 2020 Feb 5;1-9.doi: 10.1080/09546634.2020.1720579.