Dermal Cumulative Irritant Patch Study | NCT04064125

Studies
Dermal Cumulative Irritant Patch Study

NCT04064125

Sponsor

Vyne Therapeutics Inc.

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Healthy

Interventions

FMX-101

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Sep 28, 2016Actual

Completion Date

Oct 28, 2016Actual

First Submitted Date

Aug 8, 2019

First Submission Date that Met QC Criteria

Aug 19, 2019

First Posted Date

Aug 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Label	Type	Description	Intervention Names
FMX-101	Experimental		Drug: FMX-101

Name	Type	Description	Arm Group Labels	Other Names
FMX-101	Drug		FMX-101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool.		3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males or females who were 18 years of age or older.
Were of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema.

Exclusion Criteria:

Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction.
Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008911	Minocycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided