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FDA Approves New Topical for Acne


The FDA has approved tretinoin 0.05% lotion (Altreno; Ortho Dermatologics) for the treatment of acne vulgaris in patients aged 9 years and older. This treatment is the first once-daily lotion formulation of tretinoin, which is expected to improve the tolerability of the retinoid.


“Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation,” said Joshua Zeichner, MD, director of cosmetic and clinical research in the department of dermatology at Mount Sinai Hospital in New York City, New York.

Approval was based on 2 clinical trials that included 1640 participants. Participants who received tretinoin 0.05% lotion experienced statistically significant reductions in both inflammatory and non-inflammatory lesions compared with vehicle.

The most common adverse reactions, which occurred in 4% or less of participants, were dryness, pain erythema, irritation, and exfoliation. Patients receiving tretinoin 0.05% lotion should wear protective clothing and sunscreen to reduce sun exposure. Caution if patients are allergic to fish should be used for potential allergenicity to fish protein.




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