FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older, according to a news release.
FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older, according to a news release.
Epiduo had already been approved for acne treatment in children aged 12 years and older. FDA’s more recent approval was based on data from a 12-week, multicenter, randomized, vehicle-controlled, double-blind study of pediatric patients aged 9 to 11 years. The topical treatment was found to be safe and effective, with nearly 70% of patients demonstrating improvement in acne, compared to 23% in patients treated with placebo.
Common side effects reported in the study included dry skin, erythema, skin irritation and discomfort, and a skin burning sensation.
Treating a younger population with acne could help to prevent acne scarring in the future, researchers noted.
Ruxolitinib Cream Proves Safe for Young Children with Atopic Dermatitis
July 22nd 2024These results were found in the TRuE-AD3 study that was presented at the Society for Pediatric Dermatology meeting earlier this month, revealing the latest round of data collected in the TRuE-AD1 and TRuE-AD2 series of studies.
Read More
FDA Issues Complete Response for High-Dose Opioid Rescue Med
July 16th 2024OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.
Read More
Study Reveals Severe Impact of Atopic Dermatitis on Women's Quality of Life and Reproductive Health
July 15th 2024Although AD is a common condition, it’s impact on sexual function and reproductive health is not well understood. In addition, many women with AD are undertreated during pregnancy due to concerns about medication side effects.
Read More