Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01888887
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin

Condition or Disease	Intervention/Treatment	Phase
Skin Irritation	Other: Cetaphil Daily Facial Cleanser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Cetaphil Daily Facial Cleanser: 200 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cetaphil Daily Facial Cleanser All subjects receive Cetaphil Daily Facial Cleanser	Other: Cetaphil Daily Facial Cleanser

Outcome Measures

Primary Outcome Measures

1. area of erythema and edema to test reaction of skin to product [3 consecutive weeks]

   9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks will be conducted to test the reaction of the skin to the test product

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMA Laboratories	New City	New York	United States	10956

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Mayya Tastene, MD, AMA Laboratories

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01888887
• Other Study ID Numbers: GLI.04.SRE.US10236
• First Posted: Jun 28, 2013
• Last Update Posted: Jul 29, 2022
• Last Verified: Jun 1, 2013

Study Results

No Results Posted as of Jul 29, 2022