NCT04064125

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

27 days

First QC Date

August 8, 2019

Last Update Submit

August 26, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool.

    3 weeks

Study Arms (1)

FMX-101

EXPERIMENTAL
Drug: FMX-101

Interventions

FMX-101DRUG
FMX-101

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Minocycline

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 21, 2019

Study Start

September 1, 2016

Primary Completion

September 28, 2016

Study Completion

October 28, 2016

Last Updated

August 28, 2019

Record last verified: 2019-08