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. (1st May 2019)

• Record Type: Journal Article
• Authors: Lee, Y.W.; Won, C.‐H.; Jung, K.; Nam, H.‐J.; Choi, G.; Park, Y.‐H.; Park, M.; Kim, B.
• Is Part Of: British journal of dermatology. Volume 180:Number 5(2019)
• Page Start: 1030
• Page End: 1038
• Publication Date: 2019-05-01
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.17455
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Transient receptor potential vanilloid subfamily, member 1 (TRPV1) may play an important role in pruritus and inflammation induction in atopic dermatitis (AD). The treatment effect of TRPV1 antagonist via topical application in patients with AD remains unknown. Objectives: To assess the clinical efficacy and safety of PAC‐14028, a TRPV1 antagonist, via topical application in patients with AD. Methods: In this 8‐week, phase IIb, randomized, double‐blind, multicentre, vehicle‐controlled study, patients with mild‐to‐moderate AD were randomized to receive PAC‐14028 cream 0·1%, 0·3%, 1·0% or vehicle cream twice daily. The primary efficacy end point was the Investigator's Global Assessment (IGA) success rate defined as the percentage of patients with an IGA score of 0 or 1 at week 8. The secondary efficacy end points included the severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index (EASI) 75/90. Results: A total of 194 patients were enrolled. IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC‐14028 cream 0·1% ( P = 0·0025 vs. vehicle), 38·30% for PAC‐14028 cream 0·3% ( P = 0·0087 vs. vehicle) and 57·45% for PAC‐14028 cream 1·0% ( P < 0·001 vs. vehicle). In particular, statistically significant differences were found between the vehicle and treatment groups in the IGA success rates with two‐grade improvement. The SCORAD index, EASI 75/90, sleep disturbance score and pruritus visual analogue scale showed a trend towards improvement. No significant safety issues were reported. Conclusions: PAC‐14028 cream may be an effective and safe treatment modality for the treatment of patients with mild‐to‐moderate AD.