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

Vyne Therapeutics Inc.7 sites in 2 countries21 target enrollmentOctober 13, 2021

ConditionsAtopic Dermatitis

InterventionsFMX114 Vehicle

DrugsFMX114

Overview

Phase: Phase 1
Intervention: FMX114
Conditions: Atopic Dermatitis
Sponsor: Vyne Therapeutics Inc.
Enrollment: 21
Locations: 7
Primary Endpoint: Mean Change from Baseline in Atopic Dermatitis Severity Index (ADSI) score at Day 29
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

October 13, 2021

End Date

August 9, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vyne Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have the ability to understand and be willing to sign an informed consent form.
•Aged ≥ 18 years, at time of screening visit.
•Weight ≥ 40 kg, at time of screening visit.
•Diagnosis of Atopic Dermatitix with a total body surface area (BSA) of AD involvement of ≤ 35% excluding involvement of face, scalp and groin at screening and Day 1, prior to first dose.
•Atopic dermatitis should be present for at least 3 months with stable disease for ≥ 1 month at the time of the screening visit and on Day 1, prior to dose administration.
•Have the presence of at least 2 comparable target AD lesions (size approximately 10 to 200 cm2), located on the trunk, upper extremities or lower extremities. In addition, the 2 target lesions:
•must have ADSI score of ≥ 6 and ≤ 12 AND a between-lesion difference in ADSI of ≤
•must be separated by ≥ 10 cm.
•Positive varicella zoster virus (VZV) antibody test at the screening visit. At the discretion of the Investigator, subjects who return a negative result may be re-screened following a full VZV vaccination course.
•Medically healthy in the opinion of the Investigator without significant abnormalities at the screening visit and prior to dose administration on Day 1, including:

Exclusion Criteria

•In the opinion of the Investigator, subject has unstable or actively infected AD at the screening visit, or prior to dose administration on Day
•Active impetigo at any of the target lesions.
•Concomitant dermatologic conditions (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may, in the opinion of the Investigator, interfere with evaluations of the subject's response to study drug.
•Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
•Evidence or history of active, latent or inadequately treated tuberculosis (TB) infection at the screening visit.
•Evidence or history of disseminated or recurrent herpes zoster infection.
•Clinically significant active infection (in the opinion of the Investigator) within 2 weeks prior to first dose application on Day
•Any known or suspected premalignant or malignant disease within the last 5 years (excluding successfully treated basal cell carcinomas).
•Have received AD-directed therapy within the following timeframes prior to dose administration on Day 1:
•Ultraviolet A (UVA) or Ultraviolet B (UVB) therapy within 2 weeks.