Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials.
BACKGROUND
Adapalene is a new chemical entity that exhibits tretinoin-like activities in the terminal differentiation process.


OBJECTIVE
We evaluated a dose range effect of two concentrations of adapalene gel as acne treatment and compared adapalene 0.1% gel with tretinoin 0.025% gel in the treatment of acne patients in two large multicenter studies.


METHODS
Multicenter, investigator-masked, parallel group studies including 89 acne patients in the dose range study and 591 patients in the concurrent controlled studies were conducted.


RESULTS
Adapalene gel 0.1% was significantly more effective in treating acne lesions than 0.03% adapalene gel. Adapalene gel 0.1% was significantly more effective than 0.025% or tretinoin gel in one study and of the same effectiveness in the other study. Adapalene gel was always better tolerated than tretinoin gel.


CONCLUSIONS
Adapalene 0.1% gel is a safe and effective treatment of acne vulgaris.
Cunliffe
W J
WJ
General Infirmary, Leeds.
Caputo
R
R
Dreno
B
B
Förström
L
L
Heenen
M
M
Orfanos
C E
CE
Privat
Y
Y
Robledo Aguilar
A
A
Meynadier
J
J
Alirezai
M
M
Jablonska
S
S
Shalita
A
A
Weiss
J S
JS
Chalker
D K
DK
Ellis
C N
CN
Greenspan
A
A
Katz
H I
HI
Kantor
I
I
Millikan
L E
LE
Swinehart
J M
JM
Swinyer
L
L
Whitmore
C
C
Czernielewski
J
J
Verschoore
M
M
D000068816:Adapalene; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D005060:Europe; D005260:Female; D005782:Gels; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use*; D014481:United States
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D007641:Keratolytic Agents; D009281:Naphthalenes; D000068816:Adapalene; D014212:Tretinoin