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.

Correlation of photographic images from the Leeds revised acne grading system with a six-category global acne severity scale.

Background: Few global acne grading systems include individualized assessments of chest and back as well as face. The Leeds revised acne grading system is based on photographic images while the Comprehensive Acne Severity Scale (CASS) is based on textual descriptions. There exists an unmet need for a global scale based on both text and photos.

Reliability of dermatologists in acne lesion counts and global assessments.

Background: There is a paucity of data on the reliability of dermatologists in acne lesion counting and global severity assessments. The effects of training and practice on reliability are also uncertain. The objective of this study was to determine the reliability of these outcome measurements when performed by trained dermatologists.

Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD.

The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12.

Isotretinoin improves the appearance of photodamaged skin: results of a 36-week, multicenter, double-blind, placebo-controlled trial.

Photodamaged skin occurs as a result of long-term exposure to ultraviolet radiation. The incidence of photodamage in European and North American populations with Fitzpatrick skin types I, II, and III is estimated at 80% to 90%. We conducted a double-blind clinical trial to test the efficacy and safety of 0.