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.
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.
Kang
Sewon
S
Department of Dermatology, University of Michigan, Ann Arbor, Michigan, USA.
Bergfeld
Wilma
W
Gottlieb
Alice B
AB
Hickman
Janet
J
Humeniuk
John
J
Kempers
Steven
S
Lebwohl
Mark
M
Lowe
Nicholas
N
McMichael
Amy
A
Milbauer
James
J
Phillips
Tania
T
Powers
Jerold
J
Rodriguez
David
D
Savin
Ronald
R
Shavin
Joel
J
Sherer
Daniel
D
Silvis
Nancy
N
Weinstein
Richard
R
Weiss
Jonathan
J
Hammerberg
Craig
C
Fisher
Gary J
GJ
Nighland
Marge
M
Grossman
Rachel
R
Nyirady
Judit
J
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*
D007641:Keratolytic Agents; D014212:Tretinoin