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

Phase 4

Completed

• Conditions: Skin Irritation
• Interventions: Drug: Facial Moisturizer with SPF 50+

• Registration Number: NCT01892657
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-05
• Status Verified: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-04
• Results First Submitted: 2013-07-23
• Results First Submitted QC: 2013-07-23
• Results First Posted: 2013-09-25
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Facial Moisturizer with SPF 50+	Facial Moisturizer with SPF 50+	All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+

Primary Outcome Measures

Name	Time	Method
Area of Erythema and Elevated Responses of Skin to Product	3 consecutive weeks	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.

Trial Locations

Locations (1)

Thomas J. Stephens and Associates, Inc.; 🇺🇸 Colorado Springs, Colorado, United States