New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis

June 2020 | Volume 19 | Issue 6 | Original Article | 602 | Copyright © June 2020

Published online May 8, 2020

Lawrence F. Eichenfield MD,ª Emil A. Tanghetti MD,b Eric Guenin PharmD PhD MPH,c Gina Martin MOT,d Radhakrishnan Pillai PhDd

ªDepartments of Dermatology and Pediatrics; University of California, San Diego School of Medicine and Rady Children's Hospital, San Diego, CA bCenter for Dermatology and Laser Surgery, Sacramento, CA cOrtho Dermatologics*, Bridgewater, NJ dBausch Health US, LLC*, Petaluma, CA *Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.


Although prevalence of acne in adults is increasing,9 acne is primarily a disease of adolescence.2 Acne in adolescence can impact quality of life, leading to increased anxiety and depression, decreased self-confidence, and negative effects on school work and social activities.10 Treating acne in adolescents may be difficult, however, especially in younger patients, due to greater irritation from topical treatments12 and low medication adherence rates.11 With this in mind, tazarotene 0.045% lotion was formulated with emollients to improve tolerability, which may improve treatment compliance.

Topical retinoids are recommended for acne treatment in adults and adolescents based on well-established safety and efficacy, 2,21,22 but they tend to be under prescribed.2 They are very effective in addressing multiple aspects of acne pathology with comedolytic properties, resolution of preceding microcomedone lesions, and potent anti-inflammatory properties.2,4 On the other hand, retinoids may exacerbate dermatitis or eczema and are somewhat limited by side effects such as irritation, skin dryness, erythema and pain. These adverse effects may be more pronounced in younger patients12 and could compromise treatment adherence, highlighting the need to target retinoid delivery to increase efficacy and minimize side effects.4

Comparative studies have shown that tazarotene 0.1% lotion has superior efficacy to that of other retinoids such as adapalene 0.1% gel and tretinoin 0.1% microsponge.23,24 Furthermore, the tazarotene 0.045% polymeric emulsion lotion formulation presents a novel modality for enhancing drug delivery and permeation into the skin while minimizing irritation in a non-greasy, highly spreadable formulation. In the current pooled, post hoc analysis, tazarotene 0.045% lotion significantly reduced inflammatory and noninflammatory lesions at week 12 versus vehicle in patients aged 10-13 and 14-17 years and more tazarotene-treated patients in both age groups achieved treatment success at week 12. In addition, most patients reported no or mild itching, burning, and stinging. Overall rates of application site dryness and irritation with tazarotene treatment (2.6% and 0.6%) were slightly lower than those reported in studies of pediatric patients with moderate-to-severe acne treated with topical tretinoin 0.05% lotion (dryness: 2.8%-3.6%; irritation: 0.7%-1.4%).25,26

Efficacy results from the present analysis are consistent with the overall pooled population (ages 10-65 years), which also had significantly greater reductions from baseline in both inflammatory and noninflammatory lesions versus vehicle (-57.9% vs -47.8% and -56.0% vs -42.0%, respectively) at week 12.27 However, compared with the overall population, both the pre-adolescent and adolescent groups had greater numerical differences between tazarotene and vehicle treatment (Figures 4 and 5). In terms of safety and tolerability, tazarotene 0.045% lotion showed overall overall favorable safety and tolerability in the pediatric population, similar to the overall population.


This post hoc analysis of two phase 3 trials showed the polymeric, highly spreadable moisturizing formulation of tazarotene 0.045% lotion was effective and well tolerated in pre-adolescent and adolescent patients with moderate-to-severe acne. Overall AE rates were low, with favorable tolerability, which may improve patient treatment adherence and optimize efficacy, making this a promising new addition to the treatment armamentarium for acne.


Dr. Lawrence F. Eichenfield has served as an investigator and/ or consultant for Ortho Dermatologics, Galderma, Almirall and Cassiopea.

Dr. Emil Tanghetti has served as speaker for Novartis, Ortho Dermatologics, Sun, Lilly, Galderma, AbbVie, and Dermira; served as a consultant/clinical studies for Hologic, Ortho Dermatologics, and Galderma; and is a stockholder for Accure.

Dr. Eric Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.

Gina Martin and Dr. Radhakrishnan Pillai are employees of Bausch Health US, LLC and may hold stock and/or stock options in its parent company.


These studies were funded by Ortho Dermatologics. Medical writing support was provided by Lynn M. Anderson, PhD of Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.


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