Tretinoin 0.05% Lotion Is Safe, Effective, and Well-Tolerated for Inflammatory Acne


Tretinoin 0.05% lotion is safe, effective, and well-tolerated in treating moderate-to-severe acne in Hispanic patients, according to study results published in the Journal of Drugs in Dermatology.

In this post hoc analysis of 2 identical multicenter, randomized, double-blind, vehicle-controlled, parallel group clinical studies, investigators performed efficacy evaluations in Hispanic patients age 11 to 50 years with moderate to severe acne (N=766). Patients had presented with 20 to 40 inflammatory lesions, 20 to 100 noninflammatory lesions, and ≤2 nodules, as well as an Evaluator Global Severity Score (EGSS) of 3 (moderate) or 4 (severe). Efficacy end points were percentage changes from baseline to week 12 in lesion counts and the proportion of patients who achieved a ≥2-grade reduction from baseline in EGSS. Cutaneous safety (erythema and scaling) and tolerability (itchiness, burning, and stinging) were evaluated from zero (none) to 3 (severe).

There were significant reductions in both inflammatory and noninflammatory lesion counts with the use of tretinoin 0.05% lotion compared with vehicle from week 8 and week 4, respectively. Mean percentage change from baseline in inflammatory and noninflammatory lesion counts was 60.1% and 53%, respectively, compared with 51.1% (P =.001) and 38.7% (P <.001) with vehicle at week 12. At this point, 19.6% of patients were deemed treatment successes on the basis of a ≥2-grade improvement in EGSS after treatment with tretinoin 0.05% lotion compared with 12.7% on vehicle. There were more treatment-emergent adverse events in the vehicle group; 3 patients treated with tretinoin 0.05% lotion discontinued usage because of treatment-emergent adverse events. Over the study period, erythema and scaling improved with 79% and 77% of patients having no erythema or scaling by week 12 after treatment with tretinoin 0.05% lotion.

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The findings of this study indicated that tretinoin 0.05% lotion is safe, effective, and well-tolerated; the treatment was found to be statistically superior to vehicle. There is “no evidence to suggest that tretinoin 0.05% lotion caused or exacerbated existing [postinflammatory hyperpigmentation].”

Three authors acknowledge conflicts of interest. Please see the original reference for a full list of authors’ disclosures.

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Cook-Bolden FE, Weinkle SH, Guenin E, Bhatt V. Novel tretinoin 0.05% lotion for once-daily treatment of moderate-to-severe acne vulgaris in a Hispanic population. J Drugs Dermatol. 2019;18(1):32-38.