A prospective, randomised comparative study to evaluate safety, tolerability, and efficacy of topical minocycline gel 4% plus oral isotretinoin against oral isotretinoin only in Indian patients with moderate-to-severe acne vulgaris.

Introduction: The concurrent use of tetracyclines and isotretinoin in acne treatment can cause pseudotumor cerebri (PTC). However, topical minocycline (4%) was significantly less systemically absorbed.

Aim: To assess the efficacy and safety of a combination of topical minocycline gel 4% with oral isotretinoin compared to isotretinoin alone in the treatment of acne vulgaris in the Indian population.

Material and methods: This prospective, randomised, comparative study included 60 patients aged ≥ 12 years with acne. Two groups were formed: the Mino-Iso group applied minocycline gel 4% and took 20 mg isotretinoin capsules in the evening, whereas the Iso group took only 20 mg isotretinoin capsules in the evening. The study duration was 12 weeks.

Results: At week 12, the Mino-Iso group showed a significantly greater reduction in inflammatory lesions (-88.5%) than the Iso group (-67.42%) (p < 0.05). The investigator's global assessment (IGA) treatment score was statistically lower and success significantly higher in the Mino-Iso group (p < 0.05 and p = 0.03, respectively). Adverse events (AEs) were reported in 6 and 4 patients in the Mino-Iso and Iso groups, respectively (p = 0.73), all of which were mild in nature and resolved during the study.

Conclusions: The combination of topical gel 4% and oral isotretinoin 20 mg capsule significantly reduced inflammatory lesions, improved IGA scores, and had a higher success rate at week 12 than isotretinoin alone, with similar tolerability. Therefore, this combination can be considered a preferable treatment option for moderate-to-severe acne.