Tretinoin cream 0.02% for the treatment of photodamaged facial skin: A review of 2 double-blind clinical studies

In extensive clinical studies and practical use since its US Food and Drug Administration approval in 1995, tretinoin emollient cream 0.05% has been s hown to be safe and effective in the treatment of fine facial wrinkles, mot tled hyperpigmentation, and skin roughness. To provide additional prescribi ng flexibility for various patient needs, a new lower concentration formula tion, tretinoin cream, 0.02% was chosen for further development. Two multicenter, randomized, double-blind, vehicle-controlled clinical stud ies were conducted to evaluate the safety and efficacy of the lower concent ration tretinoin formulation in the treatment of moderate-to-severe facial photodamage. Results indicate statistically significant improvement in fine wrinkling, coarse wrinkling, and yellowing with the use of tretinoin cream 0.02% at week-24 end point, compared with placebo. Therapy with tretinoin cream 0.02% was well tolerated overall and demonstrated a favorable safety profile. Both studies demonstrated that tretinoin cream 0.02% is safe and e ffective for the treatment of moderate-to-severe photodamaged facial skin.