Topical proteasome inhibitor promising for rosacea treatment

Topical ACU-D1 was safe, well tolerated and efficacious in treating rosacea, according to a phase 2a study published in the Journal of Drugs in Dermatology.

ACU-D1 (pentaerythritol tetrakis (3-(3, 5-di-tert-butyl-4-hydroxyphenyl) propionate), a novel topical proteasome inhibitor, was compared with vehicle in the two-center, randomized, double-blinded, 14-week trial.

“Rosacea is a common disorder of unknown origin, but a distinct pathophysiology,” J. Mark Jackson, MD, of the division of dermatology at University of Louisville, and colleagues wrote. “The study was designed to determine whether topical ACU-D1 is safe and effective in patients and whether there were any adverse effects from active or vehicle.”

Adult patients with rosacea were randomly assigned 2:1 to receive 12 weeks of ACU-D1 or vehicle twice daily followed by 2 weeks of follow-up evaluations.

Efficacy was reported in 92% of patients in the treatment arm for reduction of inflammatory lesions.

The mean percentage reduction of inflammatory lesions was 54% at 12 weeks in subjects treated with ACU-D1, and patients with more severe disease experienced a mean percentage reduction of 59%.

Erythema reduction to 0/1 (clear or near clear) was significant in the study population compared with baseline.

Treatment-related adverse events included facial perspiration, facial warmth and facial dryness. All adverse events were mild, and none resulted in discontinuation of treatment.

“This study demonstrates that topical ACU-D1 is safe and well tolerated in humans and demonstrates efficacy in reducing inflammatory lesions and erythema in patients with moderate to severe rosacea,” the authors wrote.