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.

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.

• Authors: 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
• Journal: American journal of clinical dermatology (Am J Clin Dermatol) Vol. 6 Issue 4 Pg. 245-53 ( 2005) ISSN: 1175-0561 [Print] New Zealand
• PMID: 16060712 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Keratolytic Agents
• Tretinoin

Topics

• Administration, Topical
• Adult
• Aged
• Double-Blind Method
• Female
• Humans
• Hyperpigmentation (drug therapy)
• Keratolytic Agents (therapeutic use)
• Male
• Middle Aged
• Prospective Studies
• Skin Aging (drug effects)
• Sunlight (adverse effects)
• Tretinoin (therapeutic use)
• Ultraviolet Rays (adverse effects)