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The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris

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Abstract

Background

In two phase III clinical trials of patients with moderate-to-severe acne (NCT02932306, NCT02965456), tretinoin 0.05% lotion reduced inflammatory and noninflammatory lesions relative to vehicle lotion, with low potential for cutaneous irritation.

Objective

Data from these studies were analyzed post hoc to investigate the effects of tretinoin 0.05% lotion on patient-reported quality of life, as assessed using the Acne-Specific Quality of Life Questionnaire (Acne-QoL).

Methods

Mean changes from baseline to week 12 in Acne-QoL scores were analyzed in the pooled intent-to-treat population and a subgroup with treatment success (≥ 2-grade improvement on the Evaluator’s Global Severity Scale and rating of “clear” or “almost clear”). Pearson correlations were conducted in the pooled intent-to-treat population to assess the relationship between the Acne-QoL acne symptoms domain and each of the other three domains.

Results

In the pooled intent-to-treat population (n = 1640), greater mean improvements were found with tretinoin 0.05% lotion vs vehicle in all four domains: self-perception (mean change: 7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); acne symptoms (6.5 vs 5.6); all p < 0.05. Relative to the intent-to-treat population, participants who experienced treatment success with tretinoin 0.05% lotion had higher (better) mean Acne-QoL scores at week 12. Correlations between acne symptoms and the other three domains were found at baseline and week 12 (p < 0.05).

Conclusions

Participants with moderate-to-severe acne reported better quality of life after 12 weeks of treatment with tretinoin 0.05% lotion. Clinical improvements in acne symptoms may have contributed to these outcomes.

Trial Registration

ClinicalTrials.gov: NCT02932306, NCT02965456.

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Acknowledgements

Writing assistance was provided by Mildred Bahn at Prescott Medical Communications Group (Chicago, IL, USA) with support from Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.

Author information

Authors and Affiliations

  1. University of Texas Health Science Center, 7000 Fannin Street, Houston, TX, USA

    Stephen K. Tyring

  2. Indiana University School of Medicine, Indianapolis, IN, USA

    Leon Kircik

  3. Physicians Skin Care, PLLC, Louisville, KY, USA

    Leon Kircik

  4. Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Leon Kircik

  5. Eastern Virginia Medical School, Norfolk, VA, USA

    David M. Pariser

  6. Virginia Clinical Research Center Inc, Norfolk, VA, USA

    David M. Pariser

  7. University of Miami Miller School of Medicine, Miami, FL, USA

    Heather C. Woolery-Lloyd

  8. Dermatology and Skin Care Center of Birmingham, Birmingham, AL, USA

    Julie C. Harper

  9. Bausch Health US, LLC, Petaluma, CA, USA

    Varsha Bhatt & Radhakrishnan Pillai

  10. Ortho Dermatologics, Bridgewater, NJ, USA

    Eric Guenin

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  1. Stephen K. Tyring
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  2. Leon Kircik
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  4. Heather C. Woolery-Lloyd
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  5. Julie C. Harper
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  7. Radhakrishnan Pillai
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Corresponding author

Correspondence to Stephen K. Tyring.

Ethics declarations

Funding

The studies and analyses presented in this report were sponsored by Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.

Conflict of Interest

Stephen Tyring has acted as an investigator for Ortho Dermatologics. Leon Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. David M. Pariser has served as a consultant to Atacama Therapeutics, Bickel Biotechnology, Biofrontera AG, Celgene, Dermira, LEO, Regeneron, Sanofi, TDM SurgiTech, TheraVida, and Ortho Dermatologics; an investigator for Abbott Laboratories, Almirall, Amgen, AOBiome, Asana Biosciences, Bickel Biotechnology, Celgene, Dermavant, Dermira, Eli Lilly, LEO, Menlo Therapeutics, Merck & Co., Novartis, Novo Nordisk A/S, Ortho Dermatologics, Pfizer, Regeneron, and Stiefel; on the advisory board for Pfizer; and on the data monitoring board for BMS. Heather Woolery-Lloyd is a shareholder for Somabella Laboratories, LLC. She has served as a speaker for Aclaris and Ortho Dermatologics and a consultant for Ortho Dermatologics, and received grants/research funding from Allergan, Galderma, Nestle, Pfizer, Endo, LEO Pharma, Eirion, Golgel, and Aclaris. Julie Harper has received honoraria from Aclaris, Almirall, BioPharmX, Cassiopea, Cutanea, Dermira, Foamix, Galderma, LaRoche-Posay, Ortho Dermatologics, and Sun. Varsha Bhatt and Radhakrishnan Pillai are employees of Bausch Health US, LLC and may hold stock and/or stock options in its parent company. Eric Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.

Ethics Approval

Not applicable (post hoc analysis of data).

Consent to Participate

All participants provided written informed consent before entering the clinical trials from which the data were derived, and the trials met current standards for ethical conduct.

Consent for Publication

Not applicable.

Data Availability

Available upon request.

Code Availability

Not applicable.

Author Contributions

All authors were involved in the interpretation of data and the critical review of all manuscript drafts. All authors approved the final manuscript draft for submission and are responsible for the integrity of this work.

Additional information

Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

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Tyring, S.K., Kircik, L., Pariser, D.M. et al. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol 21, 891–899 (2020). https://doi.org/10.1007/s40257-020-00559-3

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  • DOI: https://doi.org/10.1007/s40257-020-00559-3

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