Tazarotene 0.045% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in Adult Males

January 2020 | Volume 19 | Issue 1 | Original Article | 78 | Copyright © January 2020

Published online December 13, 2019

Fran E. Cook-Bolden , Michael H. Gold , Eric Guenin

aMount Sinai Health System, New York, NY bTennnessee Clinical Research Center, Nashville, TN cOrtho Dermatologics, Bridgewater, NJ

(2.5%) gel provided data in adult (≥18 years old) and adolescent (<18 years old) males.16 Reduction in inflammatory (56.7%) and noninflammatory (44.0%) lesion counts at week 12 was greater in the adult males; but the differences between adult and adolescent males were not significant (P=0.308 and P=0.761). Treatment success was also greater in the adult males (32.6% versus 23.0%), however again differences were not significant (P=0.089). In our analysis we were able to show greater efficacy of tazarotene 0.045% lotion in adult males, whereby changes in both lesion counts and achievement of treatment success were statistically significant compared to adolescent males. The efficacy of tazarotene 0.045% lotion in adult males was also greater than that reported in the overall study populations.28

The psychological impact caused by the presence of acne seems to affect more female patients than male patients.11 In our study, QoL at baseline was much better in the adolescent males compared with the adult males. As a result, absolute increases in mean domain scores following treatment with tazarotene 0.045% lotion were greatest in adult males, however only in terms of acne symptoms was the difference significant in favor of the adult males.

Evidence-based guidelines for acne have shown retinoids to have an essential role in the management of acne.17,29 Limitations to their widespread use have included a perception of poor efficacy in inflammatory lesions and cutaneous irritation.29 Our data show tazarotene 0.045% lotion to have a comparable effect on both inflammatory and comedonal lesions, confirming other clinical data that have shown retinoids to both reduce visible lesions and inhibit the development of microcomedones and new lesions.30-32

Local skin reactions, such as erythema, scaling, dryness, burning, and stinging are well-known with retinoids. In adult males treated with tazarotene 0.045% lotion, there was a transient increase in mean scaling and burning scores at week 2, otherwise cutaneous tolerability was similar to that reported at baseline. Treatment-related AEs with tazarotene 0.045% lotion were rare, with only one report of application site pain. In contrast, AEs in the adolescent male population were similar to those reported in the overall study population.

A common complication of acne is residual postinflammatory hyperpigmentation (PIH), which causes further psychological and social distress in affected patients. Tazarotene has also been shown to significantly decrease post-inflammatory hyperpigmentation (PIH) and be more effective than other retinoids.33,34 In our study, PIH was relatively rare both at baseline and throughout treatment, perhaps in part due to the high proportion of Caucasian male subjects enrolled (78%), with no increase in mean scores over the 12-week treatment period. A longer-term study in subjects more prone to PIH is warranted.


Tazarotene 0.045% lotion is more effective and better tolerated in adult male acne than in adolescent males, with better results than those reported in the overall study populations.


Dr Cook-Bolden and Dr Gold are advisors and/or investigators with Ortho Dermatologics. Dr Guenin is an employee of Bausch Health.


We thank Brian Bulley, MSc (Konic Limited, UK) for assistance with the preparation of the manuscript. Ortho Dermatologics funded Konic’s activities pertaining to this manuscript.


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