New and emerging treatment options for acne
Research and product development shifts to targeting sebum
New and emerging prescription topical and over-the-counter acne treatments offer a new drug target, better penetration of the active drugs and, potentially, better outcomes than traditional acne treatment options, according to Leon H. Kircik, M.D., clinical associate professor of dermatology at Indiana University School of Medicine, Louisville, Ky.
Dr. Kircik spoke on the topic of emerging therapies at the Orlando Dermatology Aesthetic and Clinical Conference (Orlando, Fla., January 2016).
What’s new topical prescription acne treatment?
Recent research on severe and moderate acne patients with inflammatory acne helps to confirm the strength and efficacy of fixed dose combination gel adapalene/benzoyl peroxide 0.3%/2.5% (Epiduo Forte, Galderma), according to Dr. Kircik.
The once-daily topical’s phase 3, multicenter, randomized, double-blind, 12-week study included 50% severe and 50% moderate patients. Among the study’s findings: Epiduo Forte demonstrated superiority in the overall study population at 33.7% versus 11.0% for placebo gel at week 12 for the Investigator’s Global Assessment (IGA) Success Rate and for changes in inflammatory (-68.7% vs -39.2% ) and non-inflammatory lesion count (-68.3% vs -37.3% ). To be considered treatment successes, subjects who were severe at baseline had to finish the 12 weeks at clear or almost clear.
It’s not an easy task for any acne drug, according to Dr. Kircik.
“When you look at the IGA scale, it’s a very high bar that was put up by the FDA,” Dr. Kircik says. ”If you start severe, you have to become almost clear, and that means you have a three-grade improvement. If you start moderate, you have to be at least almost clear and have a two-grade improvement.”
Many of the patients in the study were so severe, according to Dr. Kircik, that dermatologists might want to start them on isotretinoin.
“In the study, the mean inflammatory lesion count was about 38 and noninflammatory was about 59. Average total lesion count was close to 100,” Dr. Kircik says. “I’ve done a lot of clinical studies but [this study had particularly high lesion count numbers]”.
The result: Inflammatory lesion count reduction was about 68%.
“Now, this is on the overall population, both severe and moderate,” Dr. Kircik says. “What’s impressive here, when you look at the severe population, the mean percent decrease in inflammatory lesion count was about 72% at twelve weeks.”
Even the patients in the study who were considered treatment failures by FDA standards would be happy patients, according to Dr. Kircik. The dermatologist explained IGA always trails lesion reduction.
“The problem with the IGA scale is the overall impression is very subjective, unlike the lesion count, which is objective. Here there is no counting. You walk in and look at the patient and make a decision: moderate, mild, severe. FDA tells us you cannot count the lesions. You have to do the IGA first; then, you count the lesions,” he says.