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)

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

Study Overview

• Status: Completed
• Conditions: Skin Irritation
• Intervention / Treatment: Drug: Facial Moisturizer with 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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 89015
      • Thomas J. Stephens and Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facial Moisturizer with SPF 50+; All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+	Drug: Facial Moisturizer with SPF 50+; All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+; Other Names: Cetaphil Daily Facial Moisturizer with SPF 50+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area of Erythema and Elevated Responses of Skin to Product	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.	3 consecutive weeks

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Ronald Gottschalk, MD, Galderma R&D

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Hypoallergenicity; Cetaphil Daily Facial Moisturizer with SPF 50+; Skin Irritation
• Other Study ID Numbers: GLI.04.SRE.US10093