The Food and Drug Administration (FDA) has approved Altreno (tretinoin; Ortho Dermatologics) lotion for the topical treatment of acne vulgaris in patients ≥9 years of age.
The approval was based on 2 double-blind clinical trials involving 1640 patients 9 years of age and older with moderate to severe acne vulgaris. The co-primary endpoints of the study included success on the Evaluator’s Global Severity Score (EGSS) (defined as ≥2-grade improvement from baseline and an EGSS score of clear  or almost clear ), absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count at week 12.
In Trial 1, 16.5% of Altreno-treated patients achieved success on the EGSS vs 6.9% of the vehicle arm. Patients in the Altreno group had a 47.5% mean reduction in noninflammatory facial lesions and a 50.9% mean reduction in inflammatory facial lesions compared with 27.3% and 40.4% in the vehicle arm, respectively.
In Trial 2, 19.8% of Altreno-treated patients achieved success on the EGSS vs 12.5% of the vehicle arm. Patients in the Altreno group had a 45.6% mean reduction in noninflammatory facial lesions and a 53.4% mean reduction in inflammatory facial lesions compared with 31.9% and 41.5% in the vehicle arm, respectively.
Study data also showed patient satisfaction (as assessed by 1396 surveys completed at week 12) was significantly greater with Altreno by week 12. Patients in the Altreno group saw a statistically significant increase in mean Acne-QoL assessments compared to vehicle.
Altreno, a retinoid, is supplied as a 0.05% topical lotion in 45g tubes. It is the first tretinoin product to be available in lotion form.
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