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N/A Completed N=118 Other

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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