Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test
1 other identifier
interventional
128
1 country
1
Brief Summary
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 4, 2013
CompletedResults Posted
Study results publicly available
September 25, 2013
CompletedAugust 1, 2022
August 1, 2008
2 months
July 1, 2013
July 23, 2013
July 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Facial Moisturizer with SPF 50+
EXPERIMENTALAll subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
Interventions
All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+
Eligibility Criteria
You may qualify if:
- Men or women 18 to 70 years of age in general good health
- Can read, understand, and sign informed consent
You may not qualify if:
- History of acute or chronic disease
- Diagnosed with chronic skin allergies
- Pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
Thomas J. Stephens and Associates, Inc.
Colorado Springs, Colorado, 89015, United States
Results Point of Contact
- Title
- Elizabeth M. Nieman, Medical Information Specialist
- Organization
- Galderma Laboratories, L.P.
Study Officials
- STUDY DIRECTOR
Ronald Gottschalk, MD
Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 4, 2013
Study Start
March 1, 2008
Primary Completion
May 1, 2008
Study Completion
August 1, 2008
Last Updated
August 1, 2022
Results First Posted
September 25, 2013
Record last verified: 2008-08