A tretinoin 0.05% lotion formulation has shown to be effective and well-tolerated, especially in adult female acne patients. Patients with more severe disease might show clinically significant improvement with topical monotherapy. Topical retinoids might provide realistic treatment options in these patients.

An analysis was done to evaluate the safety and effectiveness of once-daily tretinoin 0.05% lotion in adult females with moderate or severe acne. Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies were done. Adult females aged 18 years or more with moderate (N=551) and severe (N=55) acne were randomized to receive tretinoin 0.05% lotion. Once-daily application of the lotion was advised for 12 weeks.

Evaluation of efficacy included changes in baseline inflammatory/non-inflammatory lesions, treatment success (2-grade reduction in Evaluator’s Global Severity Score [EGSS] and almost clear) and quality of life (QoL) using the validated Acne-QoL survey. Safety, adverse events (AEs), and cutaneous acceptability were also evaluated.

Efficacy in adult females with moderate acne (EGSS=3) treated with tretinoin 0.05% lotion was significantly better than reported with vehicle at week 12. Mean percent reduction in inflammatory and non-inflammatory lesion counts was 58.5% and 55.5%, respectively, as compared with vehicle which was 50.3% and 39.8% with vehicle (P=0.039 and P<0.001).

Treatment success was attained by 25.4% of participants by week 12, compared with 15.4% with vehicle (P=0.006). Tretinoin 0.05% lotion was more effective in adult females with severe acne (EGSS=4). Mean percent reduction in inflammatory and non-inflammatory lesion counts was 59.0% and 58.8%, respectively as compared with vehicle which was 53.5% and 45.5%. Treatment success was attained by 17.9% of subjects compared with 4.5% with vehicle, with 46.6% of participants achieving at least a 2-grade improvement in EGSS by week 12.

Improvement in quality of life with tretinoin 0.05% lotion was significant as compared with vehicle in adult females with moderate acne, but not in severe acne. The AEs were mild and temporary. Local cutaneous safety and tolerability assessments were mild-to-moderate and had improved by week 12.

The analysis concluded that tretinoin 0.05% lotion was significantly more effective than vehicle in gaining treatment success and reducing inflammatory and non-inflammatory lesions in adult females with moderate acne to severe acne. Also, it was well-tolerated with mild adverse events.

Source: Harper JC, Baldwin H, Stein Gold L, Guenin E. Efficacy and Tolerability of a Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate or Severe Acne Vulgaris in Adult Females. J Drugs Dermatol. 2019 Nov 1; 18(11):1147-1154.