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

Galderma

Status and phase: Completed; Phase 4

Conditions: Skin Irritation

Treatments: Drug: Facial Moisturizer with SPF 50+

Study type: Interventional

Funder types: Industry

Identifiers

NCT01892657

GLI.04.SRE.US10093

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

Facial Moisturizer with SPF 50+

Experimental group

Description:

All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+

Treatment:

Drug: Facial Moisturizer with SPF 50+