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

TL;DR

A study tested a 4% minocycline gel for acne in India, finding it safe and effective for reducing acne lesions.

Contribution

This is the first phase IV clinical trial evaluating topical minocycline 4% gel in Indian patients with moderate-to-severe acne.

Findings

64.4% of patients achieved IGA treatment success after 12 weeks.

Reductions of 78% in inflammatory and 74% in non-inflammatory acne lesions were observed.

Most adverse events were mild to moderate and related to local tolerability.

Abstract

Background/objectives: With increasing resistance to clindamycin, minocycline shows low resistance rates in Cutibacterium acnes. Topical minocycline 4% foam was approved in the USA (2019) and as a gel formulation in India (2022) for moderate-to-severe acne vulgaris (AV). However, there is a paucity of clinical data regarding the use of topical minocycline in acne. This study was conducted to assess the safety, tolerability, and efficacy of topical minocycline 4% gel in Indian patients.

Methods: This 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.

Results: Of 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.

Conclusions: Topical 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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