Medication Monitor



Generic Name (Trade Name—Company)
Notes
August 29, 2018

Tretinoin 0.05% lotion

(Altreno—Ortho Dermatologics)
First formulation of tretinoin in a lotion is approved for acne

Ortho Dermatologics announced FDA approval of tretinoin 0.05% lotion as a topical treatment of acne vulgaris in patients aged 9 years and older.

The product, the first formulation of a tretinoin in a lotion, has been shown to be effective and generally well tolerated. It spreads easily and is quickly absorbed into the skin, allowing patients with acne to easily incorporate the once-daily treatment into their skin care regimen, stated the news release. 

Extensive clinical data have shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness, peeling, and sensitivity.

Tretinoin lotion was evaluated in two identical multicenter, randomized, double-blind, vehicle-controlled Phase III studies totaling 1,640 patients to determine its safety and efficacy. The data demonstrated that use of the product resulted in statistically significant reductions in both inflammatory and noninflammatory lesions compared with placebo.

The most common adverse reactions, occurring in greater than 1% of participants and greater than placebo, were dryness, pain erythema, irritation, and exfoliation. Sunscreen and protective clothing should be worn when sun exposure cannot be avoided.

The product is expected to become available during the fourth quarter of 2018.