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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
27
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.
ALS Beauty and Personal Care
Torrance, California, United States
Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
Time frame: 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.
Time frame: 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.
Time frame: 24-48 hours
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