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

NCT ID: NCT04052711

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2016-12-19

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FMX-101

Group Type EXPERIMENTAL

FMX-101

Intervention Type DRUG

Interventions

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FMX-101

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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FX2016-07

Identifier Type: -

Identifier Source: org_study_id

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