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NCT01892410 Clinical Trial

Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash

Skin Irritation Clinical Trial

Official title:
100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-Occlusive Patch)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01892410
Other study ID # GLI.04.SRE.US10235
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2012

Study information
Verified date June 2013
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Not currently under a doctor's care - Free of dermatological or systemic disorder which would interfere with the results - Free of any acute or chronic disease - Will complete a preliminary medical history form and are in general good health - Can read, understand, and sign informed consent Exclusion Criteria: - Under 18 years old - Currently under doctor's care - Currently taking any medication - History of acute or chronic disease - Diagnosed with chronic skin allergies - Pregnant or lactating

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cetaphil Restoraderm Skin Restoring Body Wash
Diluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks

Locations
Country Name City State
United States AMA Laboratories, Inc. New City New York

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area of irritation measured to determine sensitivity 9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks 3 weeks
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