User login
The first retinoid lotion for the treatment of acne vulgaris has received Food and Drug Administration approval, the manufacturer announced on Monday, March 22.
Differin Lotion 0.1% (adapalene) will be available by prescription in April for treating acne on the face and body of patients aged 12 years and older.
The approval comes after positive results were seen in two similarly designed 12-week, multicenter, controlled clinical studies comparing Differin 0.1% (Galderma) to a vehicle in 2,141 acne patients.
In both studies, Differin 0.1% was shown to significantly reduce inflammatory lesions. Dryness was the most commonly reported side effect, occurring in approximately 7% of patients during the first 2 weeks of treatment and decreasing thereafter. Other side effects included mild to moderate erythema, scaling, stinging, and burning.
"Because everyone's skin is unique, it is important to have multiple treatment options available in a variety of formulations," noted Dr. Linda Stein Gold in a press release. The lotion will help dermatologists further individualize acne treatment for their patients, said Dr. Gold, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit.
Adapalene, a third generation retinoid, was initially approved by the FDA in 1996 as a liquid solution under the same name, Differin 0.1%. The solution has since then been discontinued.
Dr. Gold is an investigator for Galderma.
The first retinoid lotion for the treatment of acne vulgaris has received Food and Drug Administration approval, the manufacturer announced on Monday, March 22.
Differin Lotion 0.1% (adapalene) will be available by prescription in April for treating acne on the face and body of patients aged 12 years and older.
The approval comes after positive results were seen in two similarly designed 12-week, multicenter, controlled clinical studies comparing Differin 0.1% (Galderma) to a vehicle in 2,141 acne patients.
In both studies, Differin 0.1% was shown to significantly reduce inflammatory lesions. Dryness was the most commonly reported side effect, occurring in approximately 7% of patients during the first 2 weeks of treatment and decreasing thereafter. Other side effects included mild to moderate erythema, scaling, stinging, and burning.
"Because everyone's skin is unique, it is important to have multiple treatment options available in a variety of formulations," noted Dr. Linda Stein Gold in a press release. The lotion will help dermatologists further individualize acne treatment for their patients, said Dr. Gold, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit.
Adapalene, a third generation retinoid, was initially approved by the FDA in 1996 as a liquid solution under the same name, Differin 0.1%. The solution has since then been discontinued.
Dr. Gold is an investigator for Galderma.
The first retinoid lotion for the treatment of acne vulgaris has received Food and Drug Administration approval, the manufacturer announced on Monday, March 22.
Differin Lotion 0.1% (adapalene) will be available by prescription in April for treating acne on the face and body of patients aged 12 years and older.
The approval comes after positive results were seen in two similarly designed 12-week, multicenter, controlled clinical studies comparing Differin 0.1% (Galderma) to a vehicle in 2,141 acne patients.
In both studies, Differin 0.1% was shown to significantly reduce inflammatory lesions. Dryness was the most commonly reported side effect, occurring in approximately 7% of patients during the first 2 weeks of treatment and decreasing thereafter. Other side effects included mild to moderate erythema, scaling, stinging, and burning.
"Because everyone's skin is unique, it is important to have multiple treatment options available in a variety of formulations," noted Dr. Linda Stein Gold in a press release. The lotion will help dermatologists further individualize acne treatment for their patients, said Dr. Gold, director of clinical research and division head of dermatology at Henry Ford Hospital in Detroit.
Adapalene, a third generation retinoid, was initially approved by the FDA in 1996 as a liquid solution under the same name, Differin 0.1%. The solution has since then been discontinued.
Dr. Gold is an investigator for Galderma.