ISSN:
1600-0536
Source:
Blackwell Publishing Journal Backfiles 1879-2005
Topics:
Medicine
Notes:
Objectives: To compare the cumulative irritancy potential of adapalene gel, 0.1% to that of tretinoin gel, 0.025% following repeated applications to the skin of human volunteers of different ethnic origins.Methods: Single center study, randomized, investigator blind, intra-individual, comparison in healthy volunteers, 18 years of age and older. Volunteers were randomized to apply each product daily to one or the other half-face for 21 days. On the forearms products were applied under occlusive conditions for 4 days. Criteria for evaluation were signs and symptoms (erythema, desquamation, dryness, stinging/ burning, pruritus) on the face and on the forearms (irritation, stinging/burning, pruritus, and biophysical measurements: colorimetry-a* and Trans-epidermal Water Loss (TEWL)). Overall safety evaluation was based on adverse events information collected throughout the study.Results: Seventy-three (73) volunteers from 4 ethnic groups (Chinese, European, Indian and Malaysian volunteers) were randomized. On the face the between treatment differences in olerability parameters were similar in all ethnic groups, thus allowing to conclude that adapalene was significantly better tolerated than tretinoin in all ethnic groups. This also allowed us to compare overall irritation susceptibility of different ethnic groups using the sum of clinical sign scores. An overall ethnic effect could be shown (p 〈 0.001): Chinese being most susceptible (33.5), followed by Indians (26.9), Malaysians (23.6) and Europeans (14.1). Forearm evaluations showed significantly better tolerability for adapalene than for tretinoin. However in each patient TEWL measurements correlated poorly with clinical assessments. Throughout the study more treatment related adverse events occurred with tretinoin than with adapalene.Conclusions: Adapalene gel, 0.1%showed a better cutaneous tolerability and safety profile than tretinoin gel, 0.025% for all four ethnic groups. An interethnic difference in the irritation susceptibility could be shown.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1111/j.0105-1873.2004.0309ag.x
Permalink
