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%) ( < 0.05). The investigator's global assessment (IGA) treatment score was statistically lower and success significantly higher in the Mino-Iso group ( < 0.05 and = 0.03, respectively). Adverse events (AEs) were reported in 6 and 4 patients in the Mino-Iso and Iso groups, respectively ( = 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.