Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892657
• Other study ID #: GLI.04.SRE.US10093
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Skin Irritation

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