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 HammerbergGary J. Fisher, Marge Nighland, Rachel Grossman, Judit Nyirady

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)245-253
Number of pages9
JournalAmerican Journal of Clinical Dermatology
Volume6
Issue number4
DOIs
StatePublished - 2005
Externally publishedYes

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Emollients
Tretinoin
Randomized Controlled Trials
Placebos
Safety
Skin
Procollagen
Therapeutics
Lentigo
Hyperpigmentation
Ambulatory Care
Cornea
Collagen
Immunohistochemistry
Research Personnel

ASJC Scopus subject areas

  • Dermatology

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

In: American Journal of Clinical Dermatology, Vol. 6, No. 4, 2005, p. 245-253.

Research output: Contribution to journalArticle

Kang, S, Bergfeld, W, Gottlieb, AB, Hickman, J, Humeniuk, J, Kempers, S, Lebwohl, M, Lowe, N, McMichael, A, Milbauer, J, Phillips, T, Powers, J, Rodriguez, D, Savin, R, Shavin, J, Sherer, D, Silvis, N, Weinstein, R, Weiss, J, Hammerberg, C, Fisher, GJ, Nighland, M, Grossman, R & Nyirady, J 2005, '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', American Journal of Clinical Dermatology, vol. 6, no. 4, pp. 245-253. https://doi.org/10.2165/00128071-200506040-00005
Kang, Sewon ; Bergfeld, Wilma ; Gottlieb, Alice B. ; Hickman, Janet ; Humeniuk, John ; Kempers, Steven ; Lebwohl, Mark ; Lowe, Nicholas ; McMichael, Amy ; Milbauer, James ; Phillips, Tania ; Powers, Jerold ; Rodriguez, David ; Savin, Ronald ; Shavin, Joel ; Sherer, Daniel ; Silvis, Nancy ; Weinstein, Richard ; Weiss, Jonathan ; Hammerberg, Craig ; Fisher, Gary J. ; Nighland, Marge ; Grossman, Rachel ; Nyirady, Judit. / 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. In: American Journal of Clinical Dermatology. 2005 ; Vol. 6, No. 4. pp. 245-253.
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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). 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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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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