Cumulative irritation potential and contact sensitization potential of tazarotene
foam 0.1% in 2 phase 1 patch studies.
Author(s): Berg JE, Bowman JP, Saenz AB.
Affiliation(s): Hill Top Research, St. Petersburg, Florida 33710, USA. jberg@hill-top.com
Publication date & source: 2012, Cutis. , 90(4):206-11
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.
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