Novel PPARγ modulator shows therapeutic potential in acne vulgaris
In the treatment of patients with acne vulgaris, the investigational peroxisome proliferator-activated receptor-γ (PPARγ) modulator N-acetyl-GED-0507-34-LEVO (NAC-GED) 5% gel appears to help clear lesions and improve acne severity while being safe, according to the results of a phase IIb study.
The study included 450 patients aged 12–30 years with facial acne, an Investigator Global Assessment (IGA) score of 3–4, and an inflammatory and noninflammatory lesion count of 20–100. They were randomized to treatment with the study drug (2% [n=150] or 5% [n=150]) or placebo (vehicle; n=150), topically applied once daily for 12 weeks.
Researchers evaluated percentage change from baseline in total lesion count (TLC) and IGA success at week 12 as the co-primary efficacy endpoints. They also assessed safety.
At baseline, IGA score was 3 in 418 (92.9 percent) patients and 4 in 32 (7.1 percent). The percentage change in TLC reduction at week 12 was much higher with both NAC-GED 5% (–57.1 percent, 95 percent confidence interval [CI], –60.8 to –53.4; p<0.001) and NAC-GED 2% (–44.7 percent, 95 percent CI, –49.1 to –40.1; p<0.001) than with the vehicle (–33.9 percent, 95 percent CI, –37.6 to –30.2).
Meanwhile, significantly more patients treated with NAC-GED 5% vs the vehicle achieved IGA success (45 percent, 95 percent CI, 38–53 vs 24 percent, 95 percent CI, 18–31; p<0.001). The IGA success rate with NAC-GED 2% was only numerically higher than the vehicle (33 percent).
The percentage of patients who had one or more adverse events was 19 percent with NAC-GED 5%, 16 percent with NAC-GED 2%, and 19 percent with the vehicle.
The findings suggest that the PPARγ receptor represents a therapeutic target for acne.