FDA Clears First Tretinoin Lotion for Acne (Altreno)

Megan Brooks

Disclosures

August 27, 2018

The US Food and Drug Administration (FDA) has approved once-daily tretinoin 0.05% lotion (Altreno, Ortho Dermatologics) for treatment of acne vulgaris in patients aged 9 years and older, making it the first tretinoin product to be available in lotion form.

While topical retinoids have proven highly effective in treating acne, they may be associated with skin irritation, such as dryness and peeling, and sensitivity. "In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients," the company said in a news release.

Altreno was evaluated in two phase 3, double-blind, vehicle-controlled clinical trials involving a total of 1640 patients aged 9 years and older. In both studies, Altreno lotion resulted in statistically significant reductions in both inflammatory and noninflammatory lesions compared with vehicle.

At week 12, 16.5% and 19.8% of Altreno-treated patients in trials 1 and 2, respectively, achieved treatment success, defined as at least a 2-grade improvement in global severity by Evaluator Global Severity Scores (EGSS) and EGSS score of clear or almost clear, compared with 6.9% and 12.5% of patients treated with vehicle. Patient satisfaction and acne quality-of-life assessments also favored Altreno over vehicle at week 12.

The most common adverse reactions occurring in more than 1% of participants and greater than with vehicle were dryness, pain erythema, irritation, and exfoliation.

Sunscreen and protective clothing should be worn when sun exposure cannot be avoided. Altreno should be used with caution in patients who are allergic to fish because of potential for allergenicity to fish protein. Full prescribing information is available online.  

The company expects Altreno to be available later this year.

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