Cumulative irritation comparison of adapalene gel and solution with 2 tazarotene gels and 3 tretinoin formulations.
Forty-two subjects with normal skin were enrolled in a single-center study to assess the cumulative irritancy potential of adapalene (Differin gel 0.1% and Differin solution 0.1%) compared with tazarotene (Tazorac gels 0.05% and 0.1%), tretinoin (Retin-A Micro gel 0.1%, Avita cream 0.025%, and Avita gel 0.025%), and white petrolatum (negative control). All test materials were applied randomly, under occlusion, to sites located on either side of the midline--the mid thoracic area of the subjects' backs. All patches were applied daily, Monday through Friday, to the same sites, unless the degree of reaction to a test product or adhesive necessitated removal (grade 3). Thirty-eight of the 42 subjects (90.5%) completed the study. Thirty-four of those 38 subjects (89.5%) had to discontinue using both tazarotene concentrations due to intolerance. Patch discontinuations for the remaining test materials were as follows: 7 subjects discontinued use of tretinoin microsphere gel 0.1%, 3 discontinued tretinoin cream 0.025%, 1 discontinued tretinoin gel 0.025%, and 1 discontinued adapalene gel 0.1%. None of the subjects discontinued use of the white petrolatum or the adapalene solution 0.1%. Adapalene gel and solution 0.1% were statistically (P<.01) less irritating than both tazarotene gels 0.1% and 0.05%, tretinoin microsphere gel 0.1%, and tretinoin gel 0.025%, and they were not statistically different from tretinoin gel 0.025%.
Greenspan
Alan
A
TKL Research, Inc, Paramus, New Jersey, USA.
Loesche
Christian
C
Vendetti
Nancy
N
Georgeian
Kathleen
K
Gilbert
Richard
R
Poncet
Michel
M
Baker
Michael D
MD
Soto
Pascale
P
D000068816:Adapalene; D000328:Adult; D000368:Aged; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D004347:Drug Interactions; D004890:Erythema / Q000139:chemically induced* / Q000503:physiopathology; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects*; D009539:Nicotinic Acids / Q000008:administration & dosage / Q000009:adverse effects*; D011336:Probability; D012680:Sensitivity and Specificity; D023422:Skin Irritancy Tests; D014212:Tretinoin / Q000008:administration & dosage / Q000009:adverse effects*; D012176:Retinoids
D000068816:Adapalene; D003879:Dermatologic Agents; D005782:Gels; D009281:Naphthalenes; D009539:Nicotinic Acids; D014212:Tretinoin; C086827:tazarotene; D012176:Retinoids