Effects of Tazarotene 0.045% Lotion on Quality of Life in Patients With Moderate-to-Severe Acne
November 2020 | Volume 19 | Issue 11 | Original Article | 1086 | Copyright © November 2020
Published online October 30, 2020
Leon H. Kircik MD,a-c Edward Lain MD MBA,d Michael Gold MD,e,f Bruce Katz MD,a,g Hilary Baldwin MD,h Eric Guenin PharmD PhD MPH,i Anya Loncaric MS,j Radhakrishnan Pillai PhDj
aIcahn School of Medicine at Mount Sinai, New York, NY
bIndiana University School of Medicine, Indianapolis, IN
cPhysicians Skin Care, PLLC, Louisville, KY
dAustin Institute for Clinical Research, Austin, TX
eGold Skin Care Center, Nashville, TN
fTennessee Clinical Research Center, Nashville, TN
gJUVA Skin & Laser Center, New York, NY
hThe Acne Treatment and Research Center, Brooklyn, NY
iOrtho Dermatologics, Bridgewater, NJ*
jBausch Health US, LLC, Petaluma, CA*
*Ortho Dermatologics is a division of Bausch Health, US, LLC. Bausch Health US, LLC is an affiliate of Bausch Health Companies, Inc.
Abstract
Background: In two phase 3 trials (NCT03168334, NCT03168321), participants with moderate-to-severe acne had significant symptom improvements after 12 weeks of treatment with tazarotene 0.045% lotion. Given the negative psychosocial effects of acne on patients, data from these studies were analyzed to evaluate quality of life in various subgroups.
Methods: Mean changes from baseline to week 12 in Acne-Specific Quality of Life (Acne-QoL) domain and item scores were analyzed in the pooled intent-to-treat (ITT) population and in participants who were categorized as follows: Evaluator's Global Severity Score (EGSS) score=3 (“moderate”) or score=4 (“severe”) at baseline; Acne-QoL total score ≥60 (better quality of life) or <60 (worse quality of life), based on the median score at baseline. Exploratory analyses based on sex and race were also performed.
Results: In the pooled ITT population (N=1614), Acne-QoL improvements were greater with tazarotene 0.045% lotion versus vehicle lotion, with significant differences in the acne symptoms domain, 3 acne symptom items, 2 self-perception items, 1 role-emotional item, and 1 role-social item (all
P<0.05). Acne-QoL improvements with tazarotene 0.045% lotion were comparable between the EGSS subgroups. However, participants who self-reported worse quality of life at baseline (Acne-QoL total score <60) had notably greater improvements than those with better quality of life. Female and Black participants had greater Acne-QoL improvements than male and White participants.
Conclusions: Participants treated with tazarotene 0.045% lotion had significant quality-of-life improvements. Clinician-rated symptom severity appeared to have a smaller effect on Acne-QoL outcomes than participants’ own assessments of quality of life.
J Drugs Dermatol. 2020;19(11): doi:10.36849/JDD.2020.5457
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INTRODUCTION
Topical retinoids are a mainstay for the treatment of acne vulgaris (acne), a prevalent skin condition that affects an estimated 40–50 million people in the United States.1,2 However, tolerability issues associated with retinoids (eg, skin irritation or dryness) can make it difficult for patients to adhere to treatment.
Tazarotene 0.045% lotion, which is approved for the topical treatment of acne in patients 9 years and older,3 was developed using a new polymeric emulsion technology that encapsulates tazarotene and hydrating/moisturizing ingredients within an oil-in-water emulsion, separated by a three-dimensional mesh matrix.4 This easily spreadable and easy-to-use formulation allows for uniform and optimal delivery of tazarotene on the skin at lower concentrations relative to conventional formulations, as demonstrated in a phase 2 trial in which tazarotene 0.045% lotion showed comparable efficacy to tazarotene 0.1% cream but with fewer adverse events.5
In two phase 3 trials that included patients with moderate-
