American Journal of Clinical Dermatology

, Volume 6, Issue 4, pp 245–253

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

A Two-Year, Randomized, Placebo-Controlled Trial

Authors

  • Sewon Kang
    • Department of DermatologyUniversity of Michigan
  • Wilma Bergfeld
    • Department of DermatologyThe Cleveland Clinic Foundation
  • Alice B. Gottlieb
    • UMDNJ-Robert Wood Johnson Medical School
  • Janet Hickman
    • The Education & Research Foundation, Inc.
  • John Humeniuk
    • Hill Top-MedQuest Centers for Research
  • Steven Kempers
    • Minnesota Clinical Study Center
  • Mark Lebwohl
    • Mount Sinai Medical Center
  • Nicholas Lowe
    • Clinical Research Specialists
  • Amy McMichael
    • School of Medicine, Department of DermatologyWake Forest University
  • James Milbauer
    • Research Testing Laboratory
  • Tania Phillips
    • Department of DermatologyBoston University School of Medicine
  • Jerold Powers
    • Hill Top Research, Inc.
  • David Rodriguez
    • International Dermatology Research, Inc.
  • Ronald Savin
    • Savin Dermatology Center
  • Joel Shavin
    • Gwinnett Clinical Research Center, Inc.
  • Daniel Sherer
    • Mount Sinai Medical Center
  • Nancy Silvis
    • Dermatology ClinicUniversity of Arizona
  • Richard Weinstein
    • Diablo Research
  • Jonathan Weiss
    • Gwinnett Clinical Research Center, Inc.
  • Craig Hammerberg
    • Department of DermatologyUniversity of Michigan
  • Gary J Fisher
    • Department of DermatologyUniversity of Michigan
  • Marge Nighland
    • Johnson & Johnson Consumer and Personal Products Worldwide
    • Johnson & Johnson Consumer and Personal Products Worldwide
  • Judit Nyirady
    • Johnson & Johnson Consumer and Personal Products Worldwide
    • Novartis Pharmaceuticals Corporation
Original Research Article

DOI: 10.2165/00128071-200506040-00005

Cite this article as:
Kang, S., Bergfeld, W., Gottlieb, A.B. et al. Am J Clin Dermatol (2005) 6: 245. doi:10.2165/00128071-200506040-00005

Abstract

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.

Copyright information

© Adis Data Information BV 2005