Acne Lotion Gets FDA Green Light

Officials with the US Food and Drug Administration (FDA) have approved the first formulation of tretinoin 0.05% in a lotion (Altreno, Ortho Dermatologics), indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Altreno was evaluated in 2 identical multicenter, randomized, double-blind, vehicle-controlled phase 3 studies, totaling 1,640 patients to determine its safety and efficacy. The data demonstrated that the lotion resulted in statistically significant reductions in both inflammatory and noninflammatory lesions compared to vehicle. In the population of patients treated in these studies, 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 vehicle. In addition, those treated with Altreno saw a mean absolute reduction of and 17.8 and 21.9 in non-inflammatory lesions in trials 1 and 2, compared to 10.6 and 13.9 in patients treated with vehicle. Also at week 12, 16.5% and 19.8% of patients in trials 1 and 2, respectively, achieved treatment success (at least a 2- grade improvement in global severity by Evaluator Global Severity Scores and ‘clear’ or ‘almost clear’) with tretinoin 0.05% lotion, compared to only 6.9% and 12.5% with vehicle.¹

The most common adverse reactions occurring in >1% of patients and greater than vehicle were dryness, pain erythema, irritation and exfoliation. Sunscreen and protective clothing should be worn when sun exposure cannot be avoided. The press release noted that patients who are allergic to fish should use Altreno "with caution.. due to potential for allergenicity to fish protein."

Patients in the treatment group saw a statistically significant increase in mean Acne-QoL assessments compared to vehicle; increase in mean scores from baseline to week 12 with Altreno were 7.4 (self-perception, versus 6.7 for vehicle, P=.003), 6.8 (role-emotional, versus 6.0, P=.003), 4.8 (role-social, versus 4.6, P=.038) and 6.5 (acne symptoms, versus 5.6, P<.001).2

Altreno is expected to be available during the fourth quarter of 2018.

References

1. Altreno [prescribing information]. Bridgewater, NJ: Ortho Dermatologics, a division of Valeant North America LLC.

2. Ortho Dermatologics Receives FDA Approval for Altreno Lotion for Acne [press release]. Raleigh, NC. Ortho Dermatologics media. August 24, 2018. http://ortho-dermatologics.com/ Accessed August 26, 2018.