Acne Treatment Tretinoin Approved by the FDA in Lotion Form

The US Food and Drug Administration (FDA) has approved Altreno, a lotion containing .05% tretinoin, for the topical treatment of acne vulgaris in patients 9 years of age and older. This is the first lotion-based formulation of the retinoid tretinoin.

"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," said Bill Humphries, president, Ortho Dermatologics, in a statement. " 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 FDA’s decision to approve Altreno was based in part on data from 2 randomized, double-blind, vehicle-controlled phase 3 studies. A total of 1640 patients with acne vulgaris were included in the studies, and 45% were younger than 18 years of age. Patients treated with Altreno saw a mean absolute reduction of 13.1 and 13.9 in inflammatory lesions, in trials 1 and 2 respectively, compared to 10.6 and 10.7 in patients treated with the vehicle.

Additionally, at 12 weeks of treatment, 16.5% and 19.8% of patients receiving Altreno, in trials 1 and 2 respectively, achieved treatment success compared to 6.9% and 12.5% of patients randomized to receive the vehicle.

"Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation," said Joshua Zeichner, MD, director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital, New York City. "With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients."

The most commonly reported adverse reactions (occurring in >1% of participants and greater than in vehicle) were dryness, pain erythema, irritation, and exfoliation, all occurring at the application site.

Patients are advised to minimize exposure to sunlight and sunlamps, and to use sunscreen and protective clothing when exposure cannot be avoided. Caution is advised for patients allergic or sensitive to fish due to the potential for a reaction to fish protein in the product. See the full prescribing information for Altreno for further details.

Ortho Dermatologics, a division of Bausch Health Companies Inc., expects to make Altreno available during the 4^th quarter of 2018.