Novel Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Race/Ethnicity

July 2020 | Volume 19 | Issue 7 | Original Article | 727 | Copyright © July 2020


Published online June 22, 2020

Neal Bhatia MD,a Jonathan S. Weiss MD,b Neil Sadick MD,c Fran E. Cook-Bolden MD,d Stephen K. Tyring MD PhD,e Eric Guenin PharmD PhD MPH,f Anya Loncaric MS,g Susan Harris MSh

aTherapeutics Clinical Research, San Diego, CA bGeorgia Dermatology Partners, and Gwinnett Clinical Research Center, Inc., Snellville, GA cWeill Cornell Medical College, New York, NY; Sadick Dermatology, New York, NY dFran E. Cook-Bolden, MD, PLLC; Mount Sinai Hospital Center, New York, NY EUniversity of Texas Health Science Center, Houston, TX fOrtho Dermatologics,* Bridgewater, NJ gBausch Health US, LLC,* Petaluma, CA hBausch Health US, LLC,* Bridgewater, NJ *Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.



studies conducted exclusively in patients with darker skin tones. For example, in a separate study of less than 80 participants, tazarotene 0.1% cream improved facial PIH compared with baseline in participants with Fitzpatrick skin type III–VI.20 This benefit of tazarotene 0.045% lotion is not a universal effect of topical retinoids. A clinical trial comparing adapalene 0.1%, adapalene 0.3%, and tretinoin 0.05% found that 90 days of treatment with adapalene 0.3% or tretinoin 0.05% was associated with lower counts of noninflammatory and inflammatory acne lesions.11 However, study participants receiving either treatment reported higher rates of PIH and overall adverse events compared with participants in the adapalene 0.1% arm.11

Despite the large number of participants in our pooled analysis overall, the small proportion of participants who self-identified as black may have limited our findings. Our analyses found trends for improvement but no significant differences between tazarotene 0.045% lotion and vehicle lotion groups for two efficacy assessments: change in inflammatory lesion counts and treatment success by week 12. The lack of a statistical difference between tazarotene and vehicle lotion in the reduction of inflammatory lesions is likely due to the high response rate to vehicle in black participants (Figure 1B), whereas the statistical analysis of treatment success may have been limited in part by the small sample size. Although the proportions of black participants in these phase 3 trials were similar to other clinical trials in dermatology, having larger sample sizes could have increased the ability to confirm numerically small differences.21 Furthermore, racial identification does not necessarily reflect skin color or all skin characteristics.22 Additional trials of tazarotene 0.045% lotion and other acne treatments in skin of color from all backgrounds could prove useful in developing evidence-based guidelines for the diverse skin types affected by this condition.

The tolerability of tazarotene 0.045% lotion in all subgroups analyzed here was consistent with the overall population of the pooled analysis.17 The majority of TEAEs were mild or moderate in severity, and approximately 11% of TEAEs were considered related to tazarotene 0.045% lotion. Further, the incidence of application-site irritation was ≤1.2% in each group. Cutaneous irritation is a well-established adverse event associated with topical retinoids, and has been reported in 2-18% of patients for tazarotene 0.1%, 2-5.6% for various adapalene formulations, and 3.8-23.6% for various tretinoin formulations.23 While irritation can reduce treatment compliance in any patient population,14 it can also induce PIH in patients with skin of color.12 Cutaneous safety and tolerability ratings from the current analysis suggest that the lower-dose tazarotene 0.045% lotion formulation produced benefits in terms of inflammation-associated sequelae such as hyperpigmentation and erythema.

CONCLUSIONS

Tazarotene 0.045% lotion using novel polymeric emulsion technology demonstrated efficacy in this pooled analysis of two