NCT04070742

Brief Summary

Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 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

August 17, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2016

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

21 days

First QC Date

August 8, 2019

Last Update Submit

September 9, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score

    4 days

Study Arms (1)

FMX-101

EXPERIMENTAL
Drug: FMX101

Interventions

FMX101DRUG
FMX-101

Eligibility Criteria

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

You may qualify if:

  • Healthy male or female volunteers age 18 years or older
  • Has uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II, or III

You may not qualify if:

  • Has any visible disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
  • Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study

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 28, 2019

Study Start

August 17, 2016

Primary Completion

September 7, 2016

Study Completion

October 1, 2016

Last Updated

September 11, 2019

Record last verified: 2019-09