N/A
N=68
Human Repeated Insult Patch Test
Dermatitis · Allergy · Contact Allergy
Bottom Line
View on ClinicalTrials.gov: NCT03474874 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Erythema at the Patch Test Site is Evaluated for Each Participant — 0.00; 0.59; 0.00 erythema score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NeoMatriX Collagen Dressing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NeXtGen Biologics, Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erythema at the Patch Test Site is Evaluated for Each Participant |
0.00; 0.59; 0.00 | — |
| SECONDARY Sensitization Reactions |
— | — |
Summary
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin
Eligibility Criteria
Inclusion Criteria
- Adults;
- Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement;
- Subjects must be considered dependable and able to follow directions
Exclusion Criteria
- Subjects who are in ill health;
- Subjects who are taking medications other than birth control;
- Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial;
- Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials;
- Subjects with any active skin disease;
- Subjects who have heavy alcohol consumption;
- Subjects with current use or history of repeated use of street drugs;
- Subjects with a significant past medical history to potentially effect results of study;
- Subjects with immunization less than 10 days prior to the test patch application;
Data sourced from ClinicalTrials.gov (NCT03474874). 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.