COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Dermal Cumulative Irritant Patch Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04064125
Recruitment Status : Completed
First Posted : August 21, 2019
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Foamix Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: FMX-101 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : October 28, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FMX-101 Drug: FMX-101

Primary Outcome Measures :
  1. Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool. [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.
Layout table for additonal information
Responsible Party: Foamix Ltd. Identifier: NCT04064125    
Other Study ID Numbers: FX2016-08
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Anti-Infective Agents