The clinical efficacy of tretinoin 0.05% lotion for the treatment of moderate acne vulgaris in women is supported by study data published in the Journal of Drugs in Dermatology.
Investigators conducted a post hoc analysis of 2 multicenter, randomized, double-blind, vehicle-controlled, phase 3 studies of a novel tretinoin 0.05% lotion formula. In both studies, women aged ≥18 years with moderate (n=551) or severe (n=55) acne were randomly assigned (1:1) to receive either tretinoin 0.05% lotion or vehicle. Treatments were applied to the face once daily for 12 weeks. Assessed at weeks 4, 8, and 12, efficacy endpoints included change from baseline in inflammatory and noninflammatory lesion counts; quality of life (QoL) per the Acne-QoL questionnaire; and proportion of patients achieving treatment success, defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score (EGSS) and a “clear” or “almost clear” clinician evaluation at the same study visit. For patients with severe acne at baseline, treatment success was defined instead as a ≥3-grade reduction from baseline EGSS. Adverse events and cutaneous tolerability were assessed throughout the trial.
In patients with moderate acne (EGSS=3) at baseline, tretinoin 0.05% lotion demonstrated significantly greater treatment efficacy than the vehicle. Compared with vehicle, patients receiving tretinoin experienced greater mean percent reduction in inflammatory (58.5% vs 50.3%; P =.039) and noninflammatory (55.5% vs 39.8%; P <.001) lesion counts. In addition, treatment success was achieved by 25.4% of the tretinoin group at week 12 compared with 15.4% of the vehicle group (P =.006). In patients with severe acne (EGSS=4), tretinoin was associated with reductions in inflammatory and noninflammatory lesion counts compared with vehicle (59.0% vs 53.5% and 58.8% vs 45.5%, respectively; both P > .05). Treatment success was achieved by 17.9% of patients with severe acne treated with tretinoin compared with 5.4% of those treated with vehicle (P =.185). In addition, nearly half (46.6%) of patients with severe acne treated with tretinoin achieved at least a 2-grade reduction in baseline EGSS by week 12. Patients with moderate acne reported higher satisfaction with tretinoin than with vehicle (P =.002). Improvements in Acne-QoL score were generally greater in the tretinoin group than in the vehicle group. The most commonly reported adverse events were contact dermatitis, irritant dermatitis, and other forms of discomfort at the treatment site. Only 3 (1.3%) severe adverse events were recorded, with 2 related to the study drug. Overall, 7 (2.9%) patients discontinued tretinoin 0.05% treatment due to adverse events.
The small cohort size for patients with severe acne limited the statistical power of analyses in this group.
Additional research is necessary to further explore the effects of tretinoin 0.05% lotion in patients with severe acne. Overall, treatment-emergent adverse events were few, supporting the tolerability of this treatment formulation. “The low potential to cause skin irritation should help [adherence among women with acne],” the investigators wrote.
Disclosure: The study authors either serve as advisors to or are employed by Ortho Dermatologics.
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;18(11):1147-1154.