Skin Irritation Clinical Trial
Official title:
Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)
Verified date | August 2008 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.
Status | Completed |
Enrollment | 128 |
Est. completion date | August 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Men or women 18 to 70 years of age in general good health - Can read, understand, and sign informed consent Exclusion Criteria: - History of acute or chronic disease - Diagnosed with chronic skin allergies - Pregnant or lactating |
Country | Name | City | State |
---|---|---|---|
United States | Thomas J. Stephens and Associates, Inc. | Colorado Springs | Colorado |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area of Erythema and Elevated Responses of Skin to Product | Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours. | 3 consecutive weeks |
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