Phase 3 trials show significant improvement compared with placebo for moderate-to-severe acne vulgaris
TUESDAY, Oct. 15, 2018 (HealthDay News) — Tretinoin 0.05 percent lotion (ALTRENO Lotion) provides statistically significant improvement in patients with moderate-to-severe acne compared with placebo, according to two phase 3 studies published in the October issue of the Journal of Drugs in Dermatology.
Stephen K. Tyring, M.D., Ph.D., from the University of Texas Health Science Center in Houston, and colleagues evaluated the efficacy, safety, and tolerability of a novel tretinoin 0.05 percent lotion in 1,640 patients (aged 9 to 58 years) with moderate-to-severe acne. Patients were randomly assigned to receive either tretinoin 0.05 percent lotion or vehicle.
The researchers found that tretinoin 0.05 percent lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and non-inflammatory lesion counts (both P < 0.001) at week 12 and improved acne severity (P < 0.001). Treatment success (a two-grade improvement in Evaluator Global Severity Scores and "clear" or "almost clear") was reported in 18 percent of patients. For patient satisfaction (P < 0.001) and acne-specific quality-of-life domains, tretinoin 0.05 percent lotion also showed significantly greater benefits compared with 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.
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