Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of onychomycosis.

Background: Itraconazole, approved for treatment of toenail fungal infection onychomycosis, provides antifungal activity at a dosage requiring once-daily (QD) administration of 2 100-mg capsules for 12 weeks. Utilizing the Meltrex® technology delivery system, a novel 200-mg formulation of itraconazole was developed delivering the same dosage as 2 capsules in a single tablet.

Methods: This phase 3, randomized, placebo-controlled trial investigated the noninferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsules dosed QD for 12 weeks, with a 40-week follow-up period.

Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial.

Background: A new 0.3% gel formulation of adapalene has been developed.

Objective: We sought to provide evidence of the superiority of adapalene gel 0.

Treatment of photoaged skin with a cream containing 0.05% isotretinoin and sunscreens.

Aims: To determine the safety and efficacy of a cream formulation of 0.05% isotretinoin with sunscreens (SPF 15) (I+S) in the treatment of photoaged skin.

Design And Subjects: A 6-month, multicentre, randomized, double-blind, parallel-group, vehicle-controlled study of 346 subjects with photoaged skin, as defined by the presence of fine lines in the periorbital region.