title: Irritation potential of tretinoin gel microsphere pump versus adapalene plus benzoyl peroxide gel.
abstract: This single-center, investigator-blinded, randomized, split-face, phase 4 study compared the irritation potential of tretinoin gel microsphere (TGM) 0.04% in a pump dispenser with adapalene 0.1% plus benzoyl peroxide 2.5% gel (ADA-BPO 0.1%/2.5%) in a panel of 170 subjects. Participants were treated with TGM 0.04% pump on a randomly assigned side of the face and ADA-BPO 0.1%/2.5% gel on the other side of the face daily for three consecutive weeks. Expert grader assessments of erythema and dryness and subject self-assessments of burning/stinging and itching were conducted daily, except on weekends. TGM 0.04% pump was associated with better facial tolerance as demonstrated by significantly less cumulative erythema (P < 0.0001), dryness (P < 0.0001), burning/stinging (P < 0.0001) and itching (P < 0.0001) compared with ADA-BPO 0.1%/2.5% gel. While both agents were well tolerated by most patients, TGM 0.04% pump demonstrated significantly better tolerance than ADA-BPO 0.1%/2.5% gel in both neurosensory parameters and signs of contact irritation.
authors.affiliation: Department of Dermatology, University of Pennsylvania, Philadelphia, USA. jjleyden@mindspring.com
authors.forename: James J
authors.initials: JJ
authors.lastname: Leyden
authors.forename: Marge
authors.initials: M
authors.lastname: Nighland
authors.forename: Ana Beatris
authors.initials: AB
authors.lastname: Rossi
authors.forename: Ratna
authors.initials: R
authors.lastname: Ramaswamy
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000068816:Adapalene; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008863:Microspheres; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D016037:Single-Blind Method; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D007641:Keratolytic Agents; D009281:Naphthalenes; D000068816:Adapalene; D014212:Tretinoin; D001585:Benzoyl Peroxide