Novel Topical Treats Mild-to-Moderate AD
A novel topical therapy, PAC-14028, was found to effectively improve symptoms of mild to moderate atopic dermatitis (AD) in a recent study.
“Transient receptor potential vanilloid subfamily, member 1 (TRPV1) may play an important role in pruritus and inflammation induction in atopic dermatitis (AD),” the researchers wrote. However, the efficacy of TRPVI antagonists for treating AD has not been well established.
In the phase 2b, randomized, clinical trial, 194 participants with mild to moderate AD were randomized to receive 0.1%, 0.3%, 1.0% PAC-14028 (a TRPV1 antagonist) cream, or vehicle. Participants applied the treatment or vehicle twice a day for 8 weeks. The Investigator’s Global Assessment (IGA) success rate, defined as percentage of participants who achieved IGA score of 0 or 1 after 8 weeks, was assessed as the primary efficacy outcome. Secondary outcomes included Scoring Atopic Dermatitis (SCORAD) index severity and Eczema Area and Severity Index (EASI) 75/90.
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After 8 weeks of treatment, IGA success rates were 14.58% for vehicle, 42.55% for PAC-14028 0.1% cream, 38.30% for PAC-14028 0.3% cream, and 57.45% for PAC-14028 1.0% cream. The researchers found statistically significant differences in IGA success rates between the vehicle group and PAC-14028 groups, with 2-grade improvements in scores.
In addition, the SCORAD index, EASI 75/90, sleep disturbance scores, and pruritus visual analogue scale showed improvements. There were no significant safety issues.
“PAC-14028 cream may be an effective and safe treatment modality for the treatment of patients with mild to moderate AD,” the researchers concluded.
Lee YW, Won CH, Jung K, et al. Efficacy and safety of PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild-to-moderate atopic dermatitis: a phase IIb randomized trial [published online January 8, 2019]. Br J Dermatol. doi:10.1111/bjd.17455