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Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD)

 Chun Wook Park  ;  Beom Joon Kim  ;  Yang Won Lee  ;  Chonghyun Won  ;  Chang Ook Park  ;  Bo Young Chung  ;  Dong Hun Lee  ;  Kyoungmi Jung  ;  Hyun-Jin Nam  ;  Gyeyoung Choi  ;  Young-Ho Park  ;  Kyu Han Kim  ;  Miyoung Park 
 JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, Vol.149(4) : 1340-1347.e4, 2022-04 
Journal Title
Issue Date
Dermatitis, Atopic* / diagnosis ; Dermatitis, Atopic* / drug therapy ; Double-Blind Method ; Emollients / therapeutic use ; Excipients ; Humans ; Immunoglobulin A ; Pruritus / drug therapy ; Severity of Illness Index ; TRPV Cation Channels ; Treatment Outcome
Atopic dermatitis ; asivatrep ; pruritus ; transient receptor potential vanilloid subfamily member 1 (TRPV1)
Background: Asivatrep is a potent and selective antagonist of transient receptor potential vanilloid subfamily V member 1 (TRPV1), which plays an important role in itch and inflammation in atopic dermatitis (AD).

Objective: This current study aimed to evaluate the efficacy and safety of asivatrep cream in patients with AD.

Methods: For this phase 3 double-blind, vehicle-controlled study, patients aged ≥12 years with mild to moderate AD were enrolled and randomly assigned 2:1 to the 1.0% asivatrep or vehicle group for 8 weeks of twice-daily application (n = 240). The primary end point was the proportion of patients with an Investigator's Global Assessment score (IGA) of 0 or 1 at week 8. Standard safety assessments were conducted.

Results: At week 8, significantly more patients in the asivatrep group (36.0%) than in the vehicle group (12.8%) had IGA scores of 0 or 1 (P < .001); significantly more had ≥2 points of improvement on the IGA from baseline score (20.3% vs 7.7%; P = .01). The mean percentage reduction in the Eczema Area and Severity Index (EASI) score was 44.3% for the asivatrep group and 21.4% for the vehicle group at week 8 (P < .001). Significantly more asivatrep-treated patients experienced an improvement of at least 50%, 75%, and 90% on the EASI than the vehicle group. The mean ± SD change in the pruritus visual analog scale score at week 8 was -2.3 ± 2.4 for the asivatrep group and -1.5 ± 2.4 for the vehicle group (P = .02). No significant safety issues were reported.

Conclusion: Asivatrep improved clinical signs and symptoms of AD and was well tolerated.
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1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Rehabilitation Medicine (재활의학교실) > 1. Journal Papers
Yonsei Authors
Park, Jung Hyun(박중현) ORCID logo https://orcid.org/0000-0003-3262-7476
Park, Chang Ook(박창욱) ORCID logo https://orcid.org/0000-0003-3856-1201
Cho, Han Eol(조한얼) ORCID logo https://orcid.org/0000-0001-5625-3013
Hong, Juntaek(홍준택)
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