Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD).
J Allergy Clin Immunol
; 149(4): 1340-1347.e4, 2022 04.
Article
in En
| MEDLINE
| ID: mdl-34606832
ABSTRACT
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 21 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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Dermatitis, Atopic
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Humans
Language:
En
Year:
2022
Type:
Article