SPT for Sensitization of Collagen Dressing

Allergic Skin Reaction Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This will be a single center, with no randomization or blinding, study design in 30 healthy adult subjects, age 18-70 years. Based on prior experience approximately 30 subjects will be enrolled to ensure 20 subjects complete the study.

Skin response to the test product and both positive and negative controls will be evaluated and measured by an allergist. If the measured diameter is ≥3mm in response to the test product with expected reactions to both the positive and negative controls, the site will be considered a positive allergen. ;

Related Conditions & MeSH terms

• Allergic Skin Reaction
• Allergy Skin
• Hypersensitivity

• NCT number: NCT06271993
• Study type: Interventional
• Source: Covalon Technologies Inc.
• Contact: Ashley Glavis
• Phone: 424-307-5900
• Email: Ashley.Glavis@ALSGlobal.com
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Completion date: March 15, 2024