N/A
N=118
Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100
Allergic Sensitization
Bottom Line
View on ClinicalTrials.gov: NCT03450070 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation — 110 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Light Therapy Mask Cream (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation |
110 | — |
Summary
Patch Testing for device cream on human subjects
Eligibility Criteria
Inclusion Criteria
- Male or Female
- 18+ years
- Good health
- Signed and datad Informed Consent
- Signed and dated HIPAA
Exclusion Criteria
- On test at any other research lab or clinic
- Known allergy or sensitivity to cosmetics or toiletries
- Pre-existing other medical conditions
- Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
- Chronic medication which could affect the outcome of the study
- Known pregnant or nursing women
- Cancer diagnosis within the past 5 years
Data sourced from ClinicalTrials.gov (NCT03450070). 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.