Trial Outcomes & Findings for SPT for Sensitization of Collagen Dressing (NCT NCT06271993)

NCT ID: NCT06271993

Last Updated: 2024-09-19

Results Overview

The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 15-20 minutes following application
• Results posted on: 2024-09-19

Participant Flow

Unit of analysis: Skin sites

Participant milestones

Measure	Collagen Wound Dressing Application of test dressing to volar forearm skin One test dressing will be applied directly to the volar forearm skin of the subject. The site will be a minimum of 2cm from the positive and negative controls to minimize cross contamination.	Postitive Control Application of histamine to volar forearm skin One positive control will be applied directly to the volar forearm skin of the subject. The site will be a minimum of 2cm from the test and negative control to minimize cross contamination.	Negative Control Application of saline with glycerin to volar forearm skin One negative control will be applied directly to the volar forearm skin of the subject. The site will be a minimum of 2cm from the test and positive control to minimize cross contamination.
Overall Study STARTED	27 27	27 27	27 27
Overall Study COMPLETED	22 22	22 22	22 22
Overall Study NOT COMPLETED	5 5	5 5	5 5

Reasons for withdrawal

Measure	Collagen Wound Dressing Application of test dressing to volar forearm skin One test dressing will be applied directly to the volar forearm skin of the subject. The site will be a minimum of 2cm from the positive and negative controls to minimize cross contamination.	Postitive Control Application of histamine to volar forearm skin One positive control will be applied directly to the volar forearm skin of the subject. The site will be a minimum of 2cm from the test and negative control to minimize cross contamination.	Negative Control Application of saline with glycerin to volar forearm skin One negative control will be applied directly to the volar forearm skin of the subject. The site will be a minimum of 2cm from the test and positive control to minimize cross contamination.
Overall Study Not reactive to histamine	5	5	5

Baseline Characteristics

SPT for Sensitization of Collagen Dressing

Baseline characteristics by cohort

Measure	Collagen Wound Dressing With Positive and Negative Controls n=22 Participants Application of test dressing, histamine, and saline with glycerin to volar forearm skin 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.
Age, Continuous	50 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants
Fitzpatrick Skin Type I - always burn, does not tan	2 Participants n=5 Participants
Fitzpatrick Skin Type II - burn easily, tan slightly	6 Participants n=5 Participants
Fitzpatrick Skin Type III - burn moderately, tan progressively	4 Participants n=5 Participants
Fitzpatrick Skin Type IV - burn a little, always tan	6 Participants n=5 Participants
Fitzpatrick Skin Type V - rarely burn, tan intensely	4 Participants n=5 Participants
Fitzpatrick Skin Type VI - never burn, tan very intensely	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15-20 minutes following application

The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.

Outcome measures

Measure	Collagen Wound Dressing n=22 Skin sites Application of test dressing 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.	Positive Controls n=22 Skin sites Application of histamine 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.	Negative Controls n=22 Skin sites Application of 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.
Wheal Measurement	0 mm Interval 0.0 to 0.0	7.91 mm Interval 4.0 to 14.0	0.32 mm Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 6 hours (+/-30 minutes)

The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.

Outcome measures

Measure	Collagen Wound Dressing n=22 Skin sites Application of test dressing 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.	Positive Controls n=22 Skin sites Application of histamine 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.	Negative Controls n=22 Participants Application of 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.
Wheal Measurement	0 mm Interval 0.0 to 0.0	0.27 mm Interval 0.0 to 4.0	0.14 mm Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 24-48 hours

The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.

Outcome measures

Measure	Collagen Wound Dressing n=22 Skin sites Application of test dressing 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.	Positive Controls n=22 Skin sites Application of histamine 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.	Negative Controls n=22 Skin sites Application of 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.
Wheal Measurement	0 mm Interval 0.0 to 0.0	0 mm Interval 0.0 to 0.0	0 mm Interval 0.0 to 0.0

Adverse Events

Collagen Wound Dressing With Positive and Negative Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Regulatory Affairs

Covalon Technologies Inc.

Phone: 888-236-4944

Email: customerservice@covalon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place