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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: FMX-101

• Registration Number: NCT04052711
• Lead Sponsor: Vyne Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-08
• Primary Completion: 2016-11-19
• Study Completion: 2016-12-19
• Status Verified: 2019-08
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-12
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FMX-101	FMX-101	-

Primary Outcome Measures

Name	Time	Method
Assessment of recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at Challenge.	8 weeks