N/A
Completed N=118
Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100
Allergic Sensitization
Source: ClinicalTrials.gov NCT03450070 ↗
Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation — 110 Participants
Summary
Patch Testing for device cream on human subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation |
110 | — |
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. Informational only — not medical advice.