A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

Vyne Therapeutics Inc.233 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

233

Conditions

Healthy

Interventions

FMX-101DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female age 18 and older who was healthy 2. Was of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema Exclusion Criteria: \-

Outcomes

Primary Outcomes

Assessment of recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at Challenge.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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