HealthDay News — Tretinoin 0.05% lotion (Altreno Lotion; Ortho Dermatologics) provides statistically significant improvement in patients with moderate-to-severe acne, compared to placebo, according to two phase 3 studies published in the October issue of the Journal of Drugs in Dermatology.
Stephen K. Tyring, MD, PhD, from the University of Texas Health Science Center in Houston, and colleagues evaluated the efficacy, safety, and tolerability of a novel tretinoin 0.05% lotion in 1640 patients with moderate-to-severe acne aged 9 to 58 years. Patients were randomized to receive either tretinoin 0.05% lotion or vehicle.
The researchers found that tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and non-inflammatory lesion counts (both P<.001) at week 12, as well as improving acne severity (P<.001). Treatment success (a two-grade improvement in Evaluator Global Severity Scores and “clear” or “almost clear”) was reported in 18% of patients. For patient satisfaction (P<.001) and acne-specific quality-of-life domains, tretinoin 0.05% lotion also showed significantly greater benefits compared to vehicle. There were no substantive differences in tolerability between the groups. No patients discontinued treatment because of adverse events.
“We believe these new data further demonstrate the value that Altreno Lotion provides patients with acne vulgaris, and we look forward to bringing the product to market by the end of the month,” Bill Humphries, president of Ortho Dermatologics, said in a statement.
Several authors report financial ties to the pharmaceutical industry, including Ortho Dermatologics, which manufactures tretinoin. The study was sponsored by Dow Pharmaceutical Sciences.