Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Assessment of Efficacy and Safety in Patients Aged 9 Years and Older.

Topical tretinoin has been extensively studied in clinical trials, and its essential role in the treatment of acne vulgaris (acne) established through evidence-based guidelines.To evaluate efficacy, safety, and tolerability of a novel tretinoin 0.05% lotion in moderate-to-severe acne in patients aged 9 years and older.A total of 1640 patients, 9-58 years of age were randomized to receive tretinoin 0.05% lotion or vehicle in two double-blind, placebo-controlled 12-week, 2-arm, parallel group studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and acne severity using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), Acne-specific quality of life (QoL) questionnaire and assessed their facial skin for shininess/oiliness improvement. The data from these two independent studies were pooled and analyzed.Tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (both P less than .001) at week 12 and improving acne severity (P less than .001). At week 12, mean percent change in inflammatory and noninflammatory lesions were 52% and 46%, respectively. Treatment success (a 2-grade improvement in EGSS and 'clear' or 'almost clear' was reported in 18% of patients. Tretinoin 0.05% lotion also showed significantly greater benefits relative to vehicle control in terms of patient satisfaction (P less than .001) and acne-specific QoL domains. Tretinoin 0.05% lotion was very well tolerated with no substantive differences in cutaneous tolerability among treatment groups. No patients discontinued treatment because of adverse events.Data from controlled studies may differ from clinical practice.Tretinoin 0.05% lotion provides statistically significant greater efficacy than vehicle with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2018;17(10):1084-1091.