title: Cumulative irritation potential and contact sensitization potential of tazarotene foam 0.1% in 2 phase 1 patch studies.
abstract: We performed 2 phase 1 patch studies to evaluate tazarotene foam 0.1% for cumulative irritation potential (study A) and contact sensitization potential (study B). Study A participants wore patches containing active study product, vehicle foam, and positive and negative controls for 24 +/- 1 hours for 21 consecutive days. Irritation scores were statistically higher with tazarotene foam 0.1% than vehicle foam and both controls. Fourteen participants (36%) experienced product-related, application-site adverse events (AEs); all of the AEs were mild and transient. Study B participants were exposed to active product and vehicle foam for an induction and challenge phase. At the investigators discretion, participants were administered a rechallenge to evaluate for contact sensitization. Three participants demonstrated questionable sensitization reactions and underwent a rechallenge; none of the participants displayed conclusive contact sensitization. Three application-site AEs were considered to be product related; none of the AEs led to study discontinuation. Tazarotene foam 0.1% showed potential to induce irritation but a low potential for contact sensitization and an acceptable tolerability and safety profile.
authors.affiliation: Hill Top Research, St. Petersburg, Florida 33710, USA. jberg@hill-top.com
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Berg
authors.forename: James P
authors.initials: JP
authors.lastname: Bowman
authors.forename: Alessandra B Alió
authors.initials: AB
authors.lastname: Saenz
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D003877:Dermatitis, Contact / Q000175:diagnosis / Q000209:etiology*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009539:Nicotinic Acids / Q000008:administration & dosage / Q000009:adverse effects*; D010328:Patch Tests / Q000379:methods; D016037:Single-Blind Method; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D023422:Skin Irritancy Tests / Q000379:methods; D012176:Retinoids
chemical_list: D003879:Dermatologic Agents; D009539:Nicotinic Acids; C086827:tazarotene; D012176:Retinoids