title: 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).
  
  
  CONCLUSIONS
  Long-term treatment with tretinoin emollient cream 0.05% is safe and effective in subjects with moderate to severe facial photodamage.
authors.affiliation: Department of Dermatology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Sewon
authors.initials: S
authors.lastname: Kang
authors.forename: Wilma
authors.initials: W
authors.lastname: Bergfeld
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: Janet
authors.initials: J
authors.lastname: Hickman
authors.forename: John
authors.initials: J
authors.lastname: Humeniuk
authors.forename: Steven
authors.initials: S
authors.lastname: Kempers
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.forename: Nicholas
authors.initials: N
authors.lastname: Lowe
authors.forename: Amy
authors.initials: A
authors.lastname: McMichael
authors.forename: James
authors.initials: J
authors.lastname: Milbauer
authors.forename: Tania
authors.initials: T
authors.lastname: Phillips
authors.forename: Jerold
authors.initials: J
authors.lastname: Powers
authors.forename: David
authors.initials: D
authors.lastname: Rodriguez
authors.forename: Ronald
authors.initials: R
authors.lastname: Savin
authors.forename: Joel
authors.initials: J
authors.lastname: Shavin
authors.forename: Daniel
authors.initials: D
authors.lastname: Sherer
authors.forename: Nancy
authors.initials: N
authors.lastname: Silvis
authors.forename: Richard
authors.initials: R
authors.lastname: Weinstein
authors.forename: Jonathan
authors.initials: J
authors.lastname: Weiss
authors.forename: Craig
authors.initials: C
authors.lastname: Hammerberg
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Fisher
authors.forename: Marge
authors.initials: M
authors.lastname: Nighland
authors.forename: Rachel
authors.initials: R
authors.lastname: Grossman
authors.forename: Judit
authors.initials: J
authors.lastname: Nyirady
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017495:Hyperpigmentation / Q000188:drug therapy; D007641:Keratolytic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects*; D013472:Sunlight / Q000009:adverse effects*; D014212:Tretinoin / Q000627:therapeutic use*; D014466:Ultraviolet Rays / Q000009:adverse effects*
chemical_list: D007641:Keratolytic Agents; D014212:Tretinoin