CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
ColActivePlus Collagen Matrix Dressingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06271993
NCT06271993N/ACompleted

Skin Prick Test (SPT) for Skin Sensitization (Contact Allergy) of Test Product ColActive Plus Collagen Matrix Dressing

Covalon Technologies Inc.·interventional·Posted Feb 22, 2024·Updated Sep 19, 2024

In Brief

A clinical study evaluating ColActivePlus Collagen Matrix Dressing for Allergy Skin and Allergic Skin Reaction. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedFeb 22, 2024
Enrollment StartFeb 8, 2024
Primary CompletionFeb 16, 2024
TodayJul 2, 2026
Enrollment to primary: 8 daysPosted 2.4 years ago

Interventions

ColActivePlus Collagen Matrix Dressingdevice

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.