PAC‐14028 Cream Safe, Effective for Mild to Moderate Atopic Dermatitis
194 participants with mild to moderate atopic dermatitis were randomly assigned to receive vehicle cream or 0.1%, 0.3%, or 1.0% PAC‐14028 cream twice daily.
PAC‐14028, a transient receptor potential vanilloid subfamily member 1 (TRPV1) agonist, appears to be a safe and effective topical treatment for patients with mild to moderate atopic dermatitis, according to data published in the British Journal of Dermatology.
Researchers in this double‐blind, multicenter, vehicle‐controlled, 8‐week, phase IIb trial randomly assigned 194 participants with mild to moderate atopic dermatitis into groups receiving vehicle cream or 0.1%, 0.3%, or 1.0% PAC‐14028 cream twice daily. The primary efficacy end point was success rate defined as percentage of participants with an Investigator's Global Assessment (IGA) score of 1 or 0 at week 8. Secondary end points included Eczema Area and Severity Index (EASI) 75/90 and Scoring of Atopic Dermatitis (SCORAD).
At week 8, IGA success was achieved by 14.58% of participants in the vehicle cream group compared with 42.55% in the 0.1% PAC-14028 group (P =.0025 vs vehicle), 38.30% in the 0.3% PAC‐14028 group (P =.0087 vs vehicle), and 57.45% in the 1.0% PAC‐14028 group (P <.001 vs vehicle). Statistically significant differences between treatment groups and vehicle cream were particularly observed for 2-grade IGA success rate improvements from baseline (4.2% for vehicle cream; 21.3% for 0.1% PAC‐14028, P =.0121; 27.7% for 0.3% PAC‐14028, P =.0017; and 38.3% for 1.0% PAC‐14028, P <.001). Trends towards improvement were seen in EASI 75/90, SCORAD index, pruritus visual analogue scale, and sleep disturbance score for all treatment groups, with significant improvements observed in sleep disturbance score from week 3 of treatment in the 1.0% PAC‐14028 cream group (P <.05 vs vehicle). There were no significant safety issues reported.
Study investigators concluded that PAC‐14028 cream is an effective, favorably tolerable treatment option for mild to moderate atopic dermatitis. They noted that “[b]ased on these results, a phase III programme is underway to assess the efficacy and safety of PAC‐14028 topical cream 1.0% in adolescent and adult patients with mild‐to‐moderate AD (NCT02965118).”
Disclosures: Study funding was provided by AmorePacific Corporation.
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