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FDA approves Altreno for acne treatment in kids, adults
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The FDA has approved a new drug application for Altreno, a topical treatment for acne vulgaris produced by Ortho Dermatologics.
This lotion (tretinoin 0.05%) is intended for use in patients aged 9 years and older.
“Today’s FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user’s experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen,” Bill Humphries, president of Ortho Dermatologics, said in a press release. “Altreno lotion spreads easily and is quickly absorbed into the skin, allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen.”
The safety and efficacy of Altreno was assessed in two identical multicenter, randomized, double-blind, vehicle-controlled phase 3 studies, which included 1,640 patients. When compared with another vehicle, the lotion significantly reduced patients’ inflammatory lesions, with researchers observing a mean absolute reduction of 13.1% in the first trial and 13.9% in the second. Those who received a vehicle demonstrated a 10.6% reduction in the first trial and a 10.7% reduction in the second.
Furthermore, Altreno was effective against noninflammatory lesions. Researchers reported a mean absolute reduction of 17.8% in the first trial and 21.9% in the second trial when using the medication. Patients who received a vehicle demonstrated 10.6% and 13.9% reductions in noninflammatory lesions. Treatment success was observed in 16.5% and 19.8% of patients administered the lotion.
Adverse events were uncommon, with more than 1% of patients reporting dryness, pain, erythema, irritation and exfoliation. Nearly all patients (90%) were satisfied with the treatment, and this satisfaction rose by 53% by week 12 of treatment.
“Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation,” Joshua Zeichner, MD, director of cosmetic and clinical research in dermatology at Mount Sinai Hospital, said in the release. “With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients.” – by Katherine Bortz