FDA Gives Thumbs Up to New OTC Acne Treatment

Patients battling acne can now add a new medication to their regimen. The FDA has approved the over-the-counter (OTC) topical gel adapalene (Differin Gel 0.1%/Galderma Laboratories) for the treatment of acne in people 12 years or older.

Although it was originally approved in 1996 as a prescription product for acne vulgaris in patients 12 years or older, Differin Gel 0.1% is now the first retinoid drug available as OTC for acne treatment. It’s also the first to contain a new active ingredient for use since the 1980s.

A common skin condition, affecting nearly 50 million people in the US, acne can not only cause scarring, but also severe psychological effects like poor self-image, depression, and anxiety.

To test the gel’s safety and efficacy, researchers conducted five clinical trials in people with mild-to-moderate acne, using data from 1996-2016.

Results showed that on a consumer level, they could easily understand the information printed on the OTC label and appropriately check whether the product was right for them.

The maximum use trial assessed during absorption through acne-affected skin when applied daily and found that absorption was limited, therefore ensuring the gel’s safety.

Experts suggest women who are pregnant, planning to become pregnant, or breast-feeding should first consult their physician before use. Although the study had not shown specific evidence that Differin Gel 0.1% would cause birth defects in humans, some other retinoid drugs have caused birth defects, so researchers urge these women to proceed with caution.