PMID- 23259209
OWN - NLM
STAT- MEDLINE
DCOM- 20130110
LR  - 20141120
IS  - 0011-4162 (Print)
IS  - 0011-4162 (Linking)
VI  - 90
IP  - 4
DP  - 2012 Oct
TI  - Cumulative irritation potential and contact sensitization potential of tazarotene 
      foam 0.1% in 2 phase 1 patch studies.
PG  - 206-11
AB  - 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.
FAU - Berg, Jeffrey E
AU  - Berg JE
AD  - Hill Top Research, St. Petersburg, Florida 33710, USA. jberg@hill-top.com
FAU - Bowman, James P
AU  - Bowman JP
FAU - Saenz, Alessandra B Alio
AU  - Saenz AB
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Cutis
JT  - Cutis
JID - 0006440
RN  - 0 (Dermatologic Agents)
RN  - 0 (Nicotinic Acids)
RN  - 81BDR9Y8PS (tazarotene)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adult
MH  - Dermatitis, Contact/diagnosis/*etiology
MH  - Dermatologic Agents/administration & dosage/*adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nicotinic Acids/administration & dosage/*adverse effects
MH  - Patch Tests/methods
MH  - Single-Blind Method
MH  - Skin/*drug effects/pathology
MH  - Skin Irritancy Tests/methods
EDAT- 2012/12/25 06:00
MHDA- 2013/01/11 06:00
CRDT- 2012/12/25 06:00
PHST- 2012/12/25 06:00 [entrez]
PHST- 2012/12/25 06:00 [pubmed]
PHST- 2013/01/11 06:00 [medline]
PST - ppublish
SO  - Cutis. 2012 Oct;90(4):206-11.