Phase 4
N=128
Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test
Skin Irritation
Bottom Line
View on ClinicalTrials.gov: NCT01892657 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Area of Erythema and Elevated Responses of Skin to Product — 91; 68; 33; 42 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Facial Moisturizer with SPF 50+ (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area of Erythema and Elevated Responses of Skin to Product |
91; 68; 33; 42; 39; 20 | — |
Summary
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01892657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.