ArticleCureus2026
PROMISE‑MINO: A Prospective, Open‑Label, Multicenter, Single‑Arm, Phase IV Study of the Safety, Local Tolerability, and Efficacy of Topical Minocycline Hydrochloride 4% Gel in Indian Patients With Moderate‑to‑Severe Acne Vulgaris.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
14 authors.
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Abstract
BACKGROUND/
objectivesWith increasing resistance to clindamycin, minocycline shows low resistance rates in
methodsThis prospective, open-label, multicenter, non-comparative, 12-week phase IV study included 256 patients aged ≥9 years with moderate-to-severe acne vulgaris and excluded those with other facial dermatological conditions. All patients received topical minocycline 4% gel once daily for 12 weeks. The primary endpoints were the absolute local skin tolerability scores at week 12. The secondary endpoints included adverse events (AEs), changes in mean inflammatory and non-inflammatory lesion counts, and Investigator Global Assessment (IGA) treatment success at week 12 from baseline.
resultsOf 256 patients, 242 completed the study. A total of 100 adverse events (AEs) were reported in 65 patients (25.39%), of which 53 events in 42 (16.41%) were drug-related, with the majority being mild to moderate. These AEs were related to local tolerability and included pruritus (n = 26, 10.16%), erythema (n = 20, 7.81%), skin hyperpigmentation (n = 18, 7.03%), dry skin (n = 17, 6.64%), and exfoliation (n = 8, 3.13%). Reductions of 78% in inflammatory and 74% in non‑inflammatory acne lesions were observed at week 12, and 64.4% of patients achieved IGA treatment success.
conclusionsTopical minocycline 4% gel showed an acceptable safety and tolerability profile with no new safety signals. Additionally, there was a clinically significant reduction in both inflammatory and non-inflammatory lesion counts, as well as a good IGA treatment success rate. Thus, it can be considered as an alternative for managing moderate-to-severe acne vulgaris.
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