Long-Term Efficacy and Safety of Tretinoin Emollient Cream 0.05% in the Treatment of Photodamaged Facial Skin - American Journal of Clinical Dermatology

Background: Long-term (>1 year) placebo-controlled studies of tretinoin in the treatment of photodamaged skin have not been conducted. Recently, we conducted a 2-year placebo-controlled study of tretinoin emollient cream 0.05%, including histopathologic assessment of safety and analysis of markers of collagen deposition.

Objective: The objective of the study was to determine the long-term safety and efficacy of tretinoin emollient cream 0.05% in the treatment of moderate to severe facial photodamage.

Methods: A total of 204 subjects were treated with tretinoin or placebo (vehicle emollient cream) applied to the entire face once a day for up to 2 years. Clinical and histologic effects were assessed at regularly scheduled clinic visits.

Results: Treatment with tretinoin resulted in significantly greater improvement relative to placebo in clinical signs of photodamage (fine and coarse wrinkling, mottled hyperpigmentation, lentigines, and sallowness), overall photodamage severity, and investigator’s global assessment of clinical response (p < 0.05). Histologic evaluation showed no increase in keratinocytic or melanocytic atypia, dermal elastosis, or untoward effects on stratum corneum following treatment with tretinoin compared with placebo. Immunohistochemistry studies, conducted at three study centers, showed a significant increase relative to placebo in facial procollagen 1C terminal, a marker for procollagen synthesis, at month 12 (p = 0.0074).

Conclusion: Long-term treatment with tretinoin emollient cream 0.05% is safe and effective in subjects with moderate to severe facial photodamage.

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Supported by OrthoNeutrogena. Drs Grossman and Nyirady and Ms Nighland are, or were, employed by Johnson & Johnson at the time of the study, and each received equity interest in Johnson & Johnson as part of their executive compensation package during the time of their contribution to the study. Dr Nyirady is currently employed by Novartis Pharmaceuticals Corporation. Dr Savin has an equity interest in Johnson & Johnson. Drs Rodriguez, Lowe, and Bergfeld received funding to support the research from OrthoNeutrogena. Drs Shavin, Weiss, and Lebwohl have performed clinical trials and/or been consultants to several pharmaceutical companies including Johnson & Johnson companies. None of the other authors has any stock or other equity ownership in Johnson & Johnson.

Presented in part at the 61st Annual Meeting of the American Academy of Dermatology, San Francisco, CA, March 26, 2003.

We are grateful to David Silvers, MD, Columbia University, NY, Babar Rao, MD, UMDNJ, NJ, and Mark Jacobson, MD, Pathology Associates, NY, for the histologic evaluations; DZS Computer Solutions, Inc., NJ, for data management; Mark Van Buskirk, MS, NJ, for statistical analysis; and Karen Miner, PhD, NJ, for her assistance in the preparation of this report.

Authors and Affiliations

1. Department of Dermatology, University of Michigan, Ann Arbor, Michigan, USA

   Sewon Kang, Craig Hammerberg & Gary J Fisher

2. Department of Dermatology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

   Wilma Bergfeld

3. UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA

   Alice B. Gottlieb

4. The Education & Research Foundation, Inc., Lynchburg, Virginia, USA

   Janet Hickman

5. Hill Top-MedQuest Centers for Research, Greer, South Carolina, USA

   John Humeniuk

6. Minnesota Clinical Study Center, Fridley, Minnesota, USA

   Steven Kempers

7. Mount Sinai Medical Center, New York, New York, USA

   Mark Lebwohl & Daniel Sherer

8. Clinical Research Specialists, Santa Monica, California, USA

   Nicholas Lowe

9. School of Medicine, Department of Dermatology, Wake Forest University, Winston-Salem, North Carolina, USA

   Amy McMichael

10. Research Testing Laboratory, Hackensack, New Jersey, USA

    James Milbauer

11. Department of Dermatology, Boston University School of Medicine, Boston, Massachusetts, USA

    Tania Phillips

12. Hill Top Research, Inc., Scottsdale, Arizona, USA

    Jerold Powers

13. International Dermatology Research, Inc., Miami, Florida, USA

    David Rodriguez

14. Savin Dermatology Center, New Haven, Connecticut, USA

    Ronald Savin

15. Gwinnett Clinical Research Center, Inc., Snellville, Georgia, USA

    Joel Shavin & Jonathan Weiss

16. Dermatology Clinic, University of Arizona, Tucson, Arizona, USA

    Nancy Silvis

17. Diablo Research, Walnut Creek, California, USA

    Richard Weinstein

18. Johnson & Johnson Consumer and Personal Products Worldwide, 199 Grandview Road, Skillman, New Jersey, 08558-9418, USA

    Marge Nighland,  Rachel Grossman & Judit Nyirady

19. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

    Judit Nyirady

Corresponding author

Correspondence to Rachel Grossman.

Cite this article

Kang, S., Bergfeld, W., Gottlieb, A.B. et al. Long-Term Efficacy and Safety of Tretinoin Emollient Cream 0.05% in the Treatment of Photodamaged Facial Skin. Am J Clin Dermatol 6, 245–253 (2005). https://doi.org/10.2165/00128071-200506040-00005

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• Published: 21 August 2012

• Issue Date: August 2005

• DOI: https://doi.org/10.2165/00128071-200506040-00005

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