NCT04927572

Safety, Pharmacokinetics and Efficacy of FMX114 Versus Vehicle in Adults With Atopic Dermatitis

A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial With Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I/IIa Randomized, Double-Blind, Vehicle-Controlled Clinical Trial with Separate Open-Label Active Treatment Phase Evaluating the Safety, Pharmacokinetics and Efficacy of FMX114 Gel in the Treatment of Mild-to-Moderate Atopic Dermatitis in Adults

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	FMX114	Active Comparator
OTHER	Vehicle	Placebo Comparator

Timeline

• Start date: 2021-10-13
• Primary completion: 2022-08-09
• Completion: 2022-08-09
• First posted: 2021-06-16
• Last updated: 2022-08-31

Locations

7 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study