TY - JOUR
T1 - Long-Term efficacy and safety of tretinoin emollient cream 0.05% in the treatment of photodamaged facial skin
T2 - A two-year, randomized, placebo-controlled trial
AU - Kang, Sewon
AU - Bergfeld, Wilma
AU - Gottlieb, Alice B.
AU - Hickman, Janet
AU - Humeniuk, John
AU - Kempers, Steven
AU - Lebwohl, Mark
AU - Lowe, Nicholas
AU - McMichael, Amy
AU - Milbauer, James
AU - Phillips, Tania
AU - Powers, Jerold
AU - Rodriguez, David
AU - Savin, Ronald
AU - Shavin, Joel
AU - Sherer, Daniel
AU - Silvis, Nancy
AU - Weinstein, Richard
AU - Weiss, Jonathan
AU - Hammerberg, Craig
AU - Fisher, Gary J.
AU - Nighland, Marge
AU - Grossman, Rachel
AU - Nyirady, Judit
PY - 2005
Y1 - 2005
N2 - 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.
AB - 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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U2 - 10.2165/00128071-200506040-00005
DO - 10.2165/00128071-200506040-00005
M3 - Article
C2 - 16060712
AN - SCOPUS:23844542682
SN - 1175-0561
VL - 6
SP - 245
EP - 253
JO - American Journal of Clinical Dermatology
JF - American Journal of Clinical Dermatology
IS - 4
ER -