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Completed

NCT Number: NCT01892657

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

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

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Key information

Conditions

Skin Irritation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thomas J. Stephens and Associates, Inc.

Colorado Springs, Colorado, 89015, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facial Moisturizer with SPF 50+

Drug

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+

Primary outcomes

  1. Area of Erythema and Elevated Responses of Skin to Product

    Time frame: 3 consecutive weeks

    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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2013
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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