Imiquimod 2.5% and 3.75% cream for the treatment of photodamage: A meta-analysis of efficacy and tolerability in 969 randomized patients

James Del Rosso, Neil Swanson, Brian Berman, George M. Martin, Tina Lin, Ted Rosen

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Ad-hoc reports within clinical studies of imiquimod for the treatment of actinic keratosis (AK) have suggested the drug can improve both skin texture and overall signs of photodamage. Objective: We sought to assess the efficacy and tolerability of imiquimod 3.75% and 2.5% cream for the treatment of photodamage in patients with AK of the full face or balding scalp. Methods: A meta-analysis of four identical multicenter, randomized, double-blind, vehiclecontrolled studies was conducted. The studies included a total of 969 adult subjects (aged 33-91 years) with 5 to 20 visible lesions or palpable AKs in an area exceeding 25cm2 on either the face or balding scalp. Patients were randomized to imiquimod 3.75%, imiquimod 2.5%, or vehicle cream (1:1:1). Up to two packets (250mg each) were applied per dose once daily for two two-week treatment cycles, separated by a two-week notreatment interval. Photodamage improvement was assessed at study end based on subjects' baseline assessments using a seven-point scale. Local skin reactions were recorded throughout the study. Results: Combined Investigator's Global Integrated Photodamage (IGIP) score was "significantly" or "much" improved in 57.6 percent (n=175) of patients treated with imiquimod 2.5% cream and in 69.6 percent (n=208) of patients treated with imiquimod 3.75% cream versus in 25.7 percent (n=76) of patients treated with the vehicle. Mean IGIP scores at end of study were 1.67, 1.98, and 0.73, respectively (both actives P<0.0001 versus vehicle). Conclusion: Both imiquimod 2.5% and 3.75% creams showed a positive effect on photodamage when compared with the vehicle cream.

Original languageEnglish (US)
Pages (from-to)28-31
Number of pages4
JournalJournal of Clinical and Aesthetic Dermatology
Volume11
Issue number9
StatePublished - Sep 1 2018
Externally publishedYes

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imiquimod
Meta-Analysis
Actinic Keratosis
Scalp
Therapeutics
Research Personnel
Skin
Double-Blind Method

Keywords

  • Actinic Keratosis
  • Imiquimod
  • Metaanalysis
  • Photodamage
  • Topical

ASJC Scopus subject areas

  • Dermatology

Cite this

Imiquimod 2.5% and 3.75% cream for the treatment of photodamage : A meta-analysis of efficacy and tolerability in 969 randomized patients. / Rosso, James Del; Swanson, Neil; Berman, Brian; Martin, George M.; Lin, Tina; Rosen, Ted.

In: Journal of Clinical and Aesthetic Dermatology, Vol. 11, No. 9, 01.09.2018, p. 28-31.

Research output: Contribution to journalArticle

Rosso, James Del ; Swanson, Neil ; Berman, Brian ; Martin, George M. ; Lin, Tina ; Rosen, Ted. / Imiquimod 2.5% and 3.75% cream for the treatment of photodamage : A meta-analysis of efficacy and tolerability in 969 randomized patients. In: Journal of Clinical and Aesthetic Dermatology. 2018 ; Vol. 11, No. 9. pp. 28-31.
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abstract = "Background: Ad-hoc reports within clinical studies of imiquimod for the treatment of actinic keratosis (AK) have suggested the drug can improve both skin texture and overall signs of photodamage. Objective: We sought to assess the efficacy and tolerability of imiquimod 3.75{\%} and 2.5{\%} cream for the treatment of photodamage in patients with AK of the full face or balding scalp. Methods: A meta-analysis of four identical multicenter, randomized, double-blind, vehiclecontrolled studies was conducted. The studies included a total of 969 adult subjects (aged 33-91 years) with 5 to 20 visible lesions or palpable AKs in an area exceeding 25cm2 on either the face or balding scalp. Patients were randomized to imiquimod 3.75{\%}, imiquimod 2.5{\%}, or vehicle cream (1:1:1). Up to two packets (250mg each) were applied per dose once daily for two two-week treatment cycles, separated by a two-week notreatment interval. Photodamage improvement was assessed at study end based on subjects' baseline assessments using a seven-point scale. Local skin reactions were recorded throughout the study. Results: Combined Investigator's Global Integrated Photodamage (IGIP) score was {"}significantly{"} or {"}much{"} improved in 57.6 percent (n=175) of patients treated with imiquimod 2.5{\%} cream and in 69.6 percent (n=208) of patients treated with imiquimod 3.75{\%} cream versus in 25.7 percent (n=76) of patients treated with the vehicle. Mean IGIP scores at end of study were 1.67, 1.98, and 0.73, respectively (both actives P<0.0001 versus vehicle). Conclusion: Both imiquimod 2.5{\%} and 3.75{\%} creams showed a positive effect on photodamage when compared with the vehicle cream.",
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T2 - A meta-analysis of efficacy and tolerability in 969 randomized patients

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AU - Swanson, Neil

AU - Berman, Brian

AU - Martin, George M.

AU - Lin, Tina

AU - Rosen, Ted

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AB - Background: Ad-hoc reports within clinical studies of imiquimod for the treatment of actinic keratosis (AK) have suggested the drug can improve both skin texture and overall signs of photodamage. Objective: We sought to assess the efficacy and tolerability of imiquimod 3.75% and 2.5% cream for the treatment of photodamage in patients with AK of the full face or balding scalp. Methods: A meta-analysis of four identical multicenter, randomized, double-blind, vehiclecontrolled studies was conducted. The studies included a total of 969 adult subjects (aged 33-91 years) with 5 to 20 visible lesions or palpable AKs in an area exceeding 25cm2 on either the face or balding scalp. Patients were randomized to imiquimod 3.75%, imiquimod 2.5%, or vehicle cream (1:1:1). Up to two packets (250mg each) were applied per dose once daily for two two-week treatment cycles, separated by a two-week notreatment interval. Photodamage improvement was assessed at study end based on subjects' baseline assessments using a seven-point scale. Local skin reactions were recorded throughout the study. Results: Combined Investigator's Global Integrated Photodamage (IGIP) score was "significantly" or "much" improved in 57.6 percent (n=175) of patients treated with imiquimod 2.5% cream and in 69.6 percent (n=208) of patients treated with imiquimod 3.75% cream versus in 25.7 percent (n=76) of patients treated with the vehicle. Mean IGIP scores at end of study were 1.67, 1.98, and 0.73, respectively (both actives P<0.0001 versus vehicle). Conclusion: Both imiquimod 2.5% and 3.75% creams showed a positive effect on photodamage when compared with the vehicle cream.

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