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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01892657
Other study ID # GLI.04.SRE.US10093
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2008
Est. completion date August 2008

Study information

Verified date August 2008
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.


Description:

The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Facial Moisturizer with SPF 50+
All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+

Locations

Country Name City State
United States Thomas J. Stephens and Associates, Inc. Colorado Springs Colorado

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 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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