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
  • Sewon Kang
  • Wilma Bergfeld
  • Alice B. Gottlieb
  • Janet Hickman
  • John Humeniuk
  • Steven Kempers
  • Mark Lebwohl
  • Nicholas Lowe
  • Amy McMichael
  • James Milbauer
  • Tania Phillips
  • Jerold Powers
  • David Rodriguez
  • Ronald Savin
  • Joel Shavin
  • Daniel Sherer
  • Nancy Silvis
  • Richard Weinstein
  • Jonathan Weiss
  • Craig Hammerberg
  • Gary J Fisher
  • Marge Nighland
  • Rachel Grossman
  • Judit Nyirady
Original Research Article

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.

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Copyright information

© Adis Data Information BV 2005

Authors and Affiliations

  • Sewon Kang
    • 1
  • Wilma Bergfeld
    • 2
  • Alice B. Gottlieb
    • 3
  • Janet Hickman
    • 4
  • John Humeniuk
    • 5
  • Steven Kempers
    • 6
  • Mark Lebwohl
    • 7
  • Nicholas Lowe
    • 8
  • Amy McMichael
    • 9
  • James Milbauer
    • 10
  • Tania Phillips
    • 11
  • Jerold Powers
    • 12
  • David Rodriguez
    • 13
  • Ronald Savin
    • 14
  • Joel Shavin
    • 15
  • Daniel Sherer
    • 7
  • Nancy Silvis
    • 16
  • Richard Weinstein
    • 17
  • Jonathan Weiss
    • 15
  • Craig Hammerberg
    • 1
  • Gary J Fisher
    • 1
  • Marge Nighland
    • 18
  • Rachel Grossman
    • 18
  • Judit Nyirady
    • 18
    • 19
  1. 1.Department of DermatologyUniversity of MichiganAnn ArborUSA
  2. 2.Department of DermatologyThe Cleveland Clinic FoundationClevelandUSA
  3. 3.UMDNJ-Robert Wood Johnson Medical SchoolNew BrunswickUSA
  4. 4.The Education & Research Foundation, Inc.LynchburgUSA
  5. 5.Hill Top-MedQuest Centers for ResearchGreerUSA
  6. 6.Minnesota Clinical Study CenterFridleyUSA
  7. 7.Mount Sinai Medical CenterNew YorkUSA
  8. 8.Clinical Research SpecialistsSanta MonicaUSA
  9. 9.School of Medicine, Department of DermatologyWake Forest UniversityWinston-SalemUSA
  10. 10.Research Testing LaboratoryHackensackUSA
  11. 11.Department of DermatologyBoston University School of MedicineBostonUSA
  12. 12.Hill Top Research, Inc.ScottsdaleUSA
  13. 13.International Dermatology Research, Inc.MiamiUSA
  14. 14.Savin Dermatology CenterNew HavenUSA
  15. 15.Gwinnett Clinical Research Center, Inc.SnellvilleUSA
  16. 16.Dermatology ClinicUniversity of ArizonaTucsonUSA
  17. 17.Diablo ResearchWalnut CreekUSA
  18. 18.Johnson & Johnson Consumer and Personal Products WorldwideSkillmanUSA
  19. 19.Novartis Pharmaceuticals CorporationEast HanoverUSA

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