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

NCT ID: NCT01892657

Last Updated: 2022-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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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

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Skin Irritation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Facial Moisturizer with SPF 50+

All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+

Group Type EXPERIMENTAL

Facial Moisturizer with SPF 50+

Intervention Type DRUG

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

Interventions

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Facial Moisturizer with SPF 50+

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

Intervention Type DRUG

Other Intervention Names

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Cetaphil Daily Facial Moisturizer with SPF 50+

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Thomas J. Stephens and Associates, Inc.

Colorado Springs, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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GLI.04.SRE.US10093

Identifier Type: -

Identifier Source: org_study_id

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