Systematic Review On The Efficacy And Safety Of Oral Isotretinoin In The Treatment Of Moderate To Severe Acne Vulgaris In Skin Of Color (Fitzpatrick Types III-VI)

Abstract

Background: Acne vulgaris is a common inflammatory skin disorder that frequently affects adolescents and young adults. Oral isotretinoin is widely regarded as the most effective systemic therapy for moderate to severe acne; however, concerns regarding safety, relapse rates, and treatment outcomes in patients with skin of color remain important considerations.

Objective: This systematic review aimed to evaluate the efficacy and safety of oral isotretinoin in the treatment of moderate to severe acne vulgaris, with particular attention to treatment outcomes in patients with skin of color.

Methods: A systematic literature search was conducted across major biomedical databases to identify relevant studies published between 2000 and 2025. Eligible studies included randomized controlled trials, clinical trials, and observational studies evaluating oral isotretinoin therapy in patients with moderate to severe acne vulgaris. Data extraction included study design, sample size, dosing regimens, treatment duration, efficacy outcomes, relapse rates, and reported adverse effects. A narrative synthesis approach was used to summarize findings due to heterogeneity across studies.

Results: Ten studies met the inclusion criteria. The findings consistently demonstrated that oral isotretinoin significantly reduces acne lesion counts and improves disease severity. Both conventional and low-dose isotretinoin regimens were effective, although lower doses were associated with improved tolerability and slightly higher relapse rates. Common adverse effects included mucocutaneous dryness and cheilitis, which were generally mild and manageable. Evidence also suggested that combination therapy with topical retinoids may enhance treatment outcomes and help maintain remission.

Conclusion: Oral isotretinoin remains a highly effective therapy for moderate to severe acne vulgaris. Optimizing dosing strategies and incorporating adjunctive treatments may further improve safety and long-term outcomes, particularly in patients with skin of color.