A comparison of the tolerability of adapalene 0.1% cream and adapalene 0.1% lotion in healthy individuals.
Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison studies compared the tolerability of adapalene 0.1% cream with adapalene 0.1% lotion in individuals with healthy skin treated once per day for 3 weeks. At each visit, the participants were graded on erythema, scaling, dryness, and stinging/burning (scale: 0 = none to 3 = severe). On the final study visit, the participants completed a Cosmetic Acceptability Questionnaire. Adverse events were recorded at each study visit. A total of 144 participants were enrolled and 130 completed the studies (study 1, n = 66; study 2, n = 64). The lotion formulation was non-inferior to the cream for the success rates and tolerability assessments in both studies. The frequency distributions of worst scores of either 0 (none) or 1 (mild) (study 1; study 2) for adapalene lotion were erythema (98.5%; 40.7%), scaling (100%; 73.5%), dryness (100%; 68.8%), and stinging/burning (98.5%; 100%). The most common treatment-related adverse event was dryness (study 1, cream 2.7% [2 of 75] and lotion 4.0% [3/75]); study 2, cream 2.9% [2 of 69] and lotion 4.3% [3 of 69]. Both the adapalene 0.1% cream and 0.1% lotion formulations were well tolerated and acceptable to the study participants. The adapalene 0.1% lotion provides clinicians with a retinoid for the treatment of acne in a lotion formulation.
Thomas J. Stephens & Associates, Inc, Dallas Research Center, Carrollton, TX, USA.
James H
JH
Herndon
Thomas J
TJ
Stephens
Nathan S
NS
Trookman
Ronald L
RL
Rizer
Norman
N
Preston
Scott
S
Caveney
Ronald W
RW
Gottschalk
D000068816:Adapalene; D000279:Administration, Cutaneous; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects*; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
D003879:Dermatologic Agents; D009281:Naphthalenes; D000068816:Adapalene