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

Vyne Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FMX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04052711

FX2016-07

Details and patient eligibility

About

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

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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233 participants in 1 patient group

FMX-101

Experimental group

Treatment:

Drug: FMX-101