Tolerability comparison of adapalene gel, 0.3% versus tazarotene cream, 0.05% in subjects with healthy skin.
BACKGROUND
Topical retinoids, including adapalene and tazarotene, are a primary treatment choice for patients with acne. Adapalene is currently marketed in a 0.1% concentration in gel and cream formulation. A new gel containing a higher concentration (0.3%) of adapalene has been developed. In clinical studies, adapalene 0.1% concentration has proven to be better tolerated than other retinoids in skin treatment. However, the tolerability of adapalene gel 0.3% has yet to be compared to other topical retinoids.


OBJECTIVE
The purpose of this study was to compare the local cutaneous tolerability of adapalene gel 0.3% once daily versus tazarotene cream 0.05% once daily.


METHODS
Subjects reported to the investigative site each day Monday through Friday, cleansed the faced and then applied adapalene 0.3% gel to one side of the face and tazarotene 0.05% cream to the other in the presence of study personnel. For the weekends, subjects were instructed to apply the treatment at home according to the same procedure. Tolerability was assessed during each weekday visit. The study lasted for 3 weeks.


RESULTS
Tolerability results for adapalene 0.3% gel and tazarotene 0.05% cream were statistically similar throughout the study. Investigator-assessed overall tolerability was in favor of adapalene at days 19 and 22 (P=.043). A cosmetic acceptability survey also showed results were better for adapalene 0.3% gel.


CONCLUSIONS
Adapalene gel 0.3% is very well-tolerated with good cosmetic acceptability.
TKL Research, Inc, Paramus, NJ, USA.
Jonathan S
JS
Dosik
Stephanie
S
Arsonnaud
D000068816:Adapalene; D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D017453:Dermatitis, Irritant / Q000209:etiology; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; 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; D009824:Ointments; D017060:Patient Satisfaction; D011537:Pruritus / Q000139:chemically induced; D012646:Self Administration; D012879:Skin Physiological Phenomena / Q000187:drug effects; D012880:Skin Pigmentation / Q000187:drug effects; D016896:Treatment Outcome; D012176:Retinoids
D000068816:Adapalene; D003879:Dermatologic Agents; D005782:Gels; D009281:Naphthalenes; D009539:Nicotinic Acids; D009824:Ointments; C086827:tazarotene; D012176:Retinoids