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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.
 
ClinicalTrials.gov Identifier: NCT04064125
Recruitment Status : Completed
First Posted : August 21, 2019
Last Update Posted : August 28, 2019
Sponsor:
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

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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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Foamix Ltd.
ClinicalTrials.gov 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Minocycline
Anti-Bacterial Agents
Anti-Infective Agents