title: Adapalene 0.1% and benzoyl peroxide 2.5% as a fixed-dose combination gel is as well tolerated as the individual components alone in terms of cumulative irritancy.
abstract: International guidelines recommend the combination of retinoids (e.g. adapalene, tazarotene) and benzoyl peroxide for treating acne because of their complementary mechanisms of action. A new fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide (BPO) 2.5% (adapalene/BPO*) is an effective acne treatment and offers the advantage of a once daily application. This paper reports the results of a cumulative irritancy study in healthy volunteers comparing adapalene/BPO to adapalene 0.1% and BPO 2.5% applied separately, BPO 10% gel, tazarotene 0.1% gel and the gel vehicle as a control.There was no significant difference between the mean cumulative irritation index (MCII) for adapalene/BPO and any test product except tazarotene 0.1% gel, which had a significantly greater MCII than all other test products (p < 0.05). This study showed that adapalene/BPO as a fixed-dose combination is as well tolerated as BPO 2.5% gel alone or adapalene 0.1% gel alone in terms of cumulative irritancy.*Epiduo, Galderma S.A.
authors.affiliation: Galderma Research & Development, 2400 route des Colles, 06410 Biot, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Loesche
authors.forename: Colette
authors.initials: C
authors.lastname: Pernin
authors.forename: Michel
authors.initials: M
authors.lastname: Poncet
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000328:Adult; D000368:Aged; D001585:Benzoyl Peroxide / Q000008:administration & dosage*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004338:Drug Combinations; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D009281:Naphthalenes; D000068816:Adapalene; D001585:Benzoyl Peroxide