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SPT for Sensitization of Collagen Dressing

NCT06271993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-09-19

Study results available
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Summary

The goal of this clinical trial is to determine the sensitization (contact allergy) potential of the test product ColActive Plus Collagen Matrix Dressing after a skin prick test on the skin of healthy human subjects. The main question it aims to answer is:

• Does the product induce any sensitization (contact allergy) after a skin prick using a UniTest PC (pain control) device in healthy human subjects? Participants will have the test product and both positive and negative controls applied, and skin response will be evaluated by an allergist at 15 minutes, 6 hours, and 24-48 hours post-application to see if sensitization occurs.

Conditions

  • Allergy Skin
  • Allergic Skin Reaction

Interventions

DEVICE

ColActivePlus Collagen Matrix Dressing

The test product, positive control and negative control will be applied directly to the volar forearm skin of the subject. The sites will be a minimum of 2cm from each other to minimize cross contamination.

Sponsors & Collaborators

  • ALS Beauty and Personal Care

    collaborator INDUSTRY

  • Covalon Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Jordan DeSantis, MHI, BS · ALS

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-08
Primary Completion
2024-02-16
Completion
2024-02-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06271993 on ClinicalTrials.gov