Dermal Cumulative Irritant Patch Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04064125

Enrollment

Registered

2019-08-21

Start date

2016-09-01

Completion date

2016-10-28

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGFMX-101

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026