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NCT04052711 Clinical Trial

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

Healthy Clinical Trial

Official title:
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04052711
Other study ID # FX2016-07
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 8, 2016
Est. completion date December 19, 2016

Study information
Verified date August 2019
Source Foamix Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

Recruitment information / eligibility
Status Completed
Enrollment 233
Est. completion date December 19, 2016
Est. primary completion date November 19, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female age 18 and older who was healthy

2. Was of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema

Exclusion Criteria:

-

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FMX-101

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Foamix Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at Challenge. 8 weeks
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