NCT01892657

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

Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Irritation

Interventions

Type	Name	Description
DRUG	Facial Moisturizer with SPF 50+	All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-05-01
• Completion: 2008-08-01
• First posted: 2013-07-04
• Last updated: 2022-08-01
• Results posted: 2013-09-25

Locations

1 site across 1 country: United States