Comparison of efficacy of topical tretinoin 0.05% cream with placebo in treatment of melasma

ABSTRACT

Melasma is a common disorder of macular hyperpigmentation, which involves mostly in sun-exposed areas of face and neck. Women are more affected. Multiple factors have been postulated to involve in the etiology and pathogenesis of melasma including pregnancy, oral contraceptives, genetics, sun exposure, cosmetics and race. Fifty women completed a randomized, double blind vehicle controlled clinical trial, in which they applied 0.05% tretinoin [n=25] or vehicle cream [n=25] once daily on the face for 12 weeks. 2 weeks after treatment 6 out of 25[24%] tretinoin-treated patients [group 1] were clinically improved, compared with 0 out of 25[0%] in the vehicle group [group2][p=0.022]. 4 weeks after treatment 14[56%] of groupl and 5[20%] of group2 improved [p=0.006]. After 12 weeks, 21 [84%] of groupl and 6[24%] ofgroup2 were improved [p=0.0001] which demonstrated significant improvement in the tretinoin-treated patients compared with the vehicle group. This controlled study demonstrates that topical 0.05% tretinoin alone is considered to be effective in the treatment of melasma patients