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

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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)

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+

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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