SPT for Sensitization of Collagen Dressing
Skin Prick Test (SPT) for Skin Sensitization (Contact Allergy) of Test Product ColActive Plus Collagen Matrix Dressing
Sponsor study identifier
interventional
27
1 country
1
Study Start
February 8, 2024
Actual (reported)Primary Completion
February 16, 2024
Actual (reported)Study Completion
February 16, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 16, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2024
Actual (reported)February 15, 2024
Actual (reported)February 16, 2024
Actual (reported)February 16, 2024
Actual (reported)February 22, 2024
Actual (reported)September 19, 2024
Actual (reported)Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
15-20 minutes following application
Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
6 hours (+/-30 minutes)
Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
24-48 hours
Application of test dressing, histamine, and saline with glycerin to volar forearm skin
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ALS Beauty and Personal Care
Torrance, California, 90501, United States
Jordan DeSantis, MHI, BS
ALS
27 participants (actual enrollment reported by the registry).
First Submitted
February 15, 2024
First Posted
February 22, 2024
Study Start
February 8, 2024
Determination of Blomia Tropicalis Allergen Extract in Prick Test Units
Contact the study team to confirm eligibility.
Primary Completion
February 16, 2024
Actual (reported)Study Completion
February 16, 2024
Actual (reported)Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: