Journal of the American Academy of Dermatology
Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials☆,☆☆
Section snippets
Patients and methods
This controlled study was performed in two centers on two parallel groups. Patients received, according to a predetermined randomization scheme using the Latin square method, one of three treatments: 0.03% adapalene gel, 0.1% adapalene gel, or 0.025% tretinoin gel. In view of the different physical appearance of the tested formulations, the treatments were dispensed by someone other than the investigator and therefore investigators were blinded to treatment assignment.
Treatments were applied to
Study II: Adapalene 0.1% versus tretinoin, U.S. multicenter controlled study
This U.S. multicenter randomized, investigator-masked trial was designed to compare the efficacy and safety of adapalene gel 0.1% with tretinoin gel 0.025% in the treatment of acne vulgaris. The study was performed by the following main investigators: A. Shalita (Brooklyn, NY), J.S. Weiss (Atlanta, GA), D.K. Chalker (Augusta, GA), C.N. Ellis (Ann Arbor, MI), A. Greenspan (Maywood, NJ), H.I. Katz (Fridley, MN), I. Kantor (Great Neck, NY), L.E. Millikan (New Orleans, LA), T. Swinehart (Denver
1) Study I: Dose range study results
A total of 89 male and female patients were included in Study I; 45 in Montpellier and 44 in Warsaw. In total, 29 patients received 0.03% adapalene gel, 30 patients 0.1% adapalene gel, and 30 patients 0.025% tretinoin. During the study, eight dropouts occurred: three for ineffectiveness after 8 weeks of treatment, and five for reasons not related to treatment.
A regular decrease in the number of acne lesions was observed during the study in the three comparative groups of patients (Fig. 1) .
DISCUSSION
The efficacy of tretinoin for the treatment of acne vulgaris has been demonstrated in several studies comparing 0.1%, 0.05%, and 0.025% concentrations in various vehicles to the vehicle alone. 13 To determine the efficacy of adapalene gel, the highest commercially available strength of tretinoin gel was chosen. For this reason, adapalene gel 0.1% was compared with tretinoin gel 0.025% in two large multicenter trials.
After a 12-week treatment of patients with mild to moderate acne vulgaris
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