An interventional study of ColActivePlus Collagen Matrix Dressing in Allergy Skin and Allergic Skin Reaction, sponsored by Covalon Technologies Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Covalon Technologies Inc. · Not applicable, Interventional, and Other
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:
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 27 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Covalon Technologies Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application of test dressing, histamine, and saline with glycerin to volar forearm skin
Device: 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.
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
| Milestone | Collagen Wound Dressing | Postitive Control | Negative Control |
|---|---|---|---|
| Started | 27 | 27 | 27 |
| Completed | 22 | 22 | 22 |
| Not completed | 5 | 5 | 5 |
| Withdrew: Not reactive to histamine | 5 | 5 | 5 |
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
| mm | Collagen Wound Dressing | Positive Controls | Negative Controls |
|---|---|---|---|
| Wheal Measurement | 0 (0 to 0) | 7.91 (4 to 14) | 0.32 (0 to 4) |
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
| mm | Collagen Wound Dressing | Positive Controls | Negative Controls |
|---|---|---|---|
| Wheal Measurement | 0 (0 to 0) | 0.27 (0 to 4) | 0.14 (0 to 3) |
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
| mm | Collagen Wound Dressing | Positive Controls | Negative Controls |
|---|---|---|---|
| Wheal Measurement | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
Collected over 2 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Collagen Wound Dressing With Positive and Negative Controls | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Collagen Wound Dressing With Positive and Negative Controls |
|---|---|
| Mean | 50 ± 14 |
| Sex: Female, Male(Participants) | Collagen Wound Dressing With Positive and Negative Controls |
|---|---|
| Female | 16 |
| Male | 6 |
| Race/Ethnicity, Customized(Participants) | Collagen Wound Dressing With Positive and Negative Controls |
|---|---|
| Race — African American | 4 |
| Race — Asian | 4 |
| Race — Caucasian | 4 |
| Race — Hispanic | 8 |
| Race — Other | 2 |
| Region of Enrollment(Participants) | Collagen Wound Dressing With Positive and Negative Controls |
|---|---|
| United States | 22 |
| Fitzpatrick Skin Type(Participants) | Collagen Wound Dressing With Positive and Negative Controls |
|---|---|
| I - always burn, does not tan | 2 |
| II - burn easily, tan slightly | 6 |
| III - burn moderately, tan progressively | 4 |
| IV - burn a little, always tan | 6 |
| V - rarely burn, tan intensely | 4 |
| VI - never burn, tan very intensely | 0 |
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Plan to share: No
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Covalon Technologies Inc.