Trial Outcomes & Findings for HRIPT for Collagen Dressing (NCT NCT06283173)

Last Updated: 2025-03-12

Results Overview

Inflammatory response graded as 0 through 3: 0=no visible reaction; +=slight, confluent, or patchy erythema; 1=Mild erythema (pink); 2=moderate erythema (definite redness); 3=strong erythema (very intense redness) Definition of letter grades appended to a numerical grade: E = Edema - swelling, spongy feeling when palpated P = Papule - red, solid, pinpoint elevation V = Vesicle - small elevation containing fluid B = Bulla reaction - fluid-filled lesion (blister) S = Spreading - evidence of the reaction beyond the Webril® pad area W = Weeping - result of a vesicular or bulla reaction - serous exudate I = Induration - solid, elevated, hardened, thickened skin Superficial Effects g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish-brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring - grooves in the superficial layers of the skin

Recruitment status

COMPLETED

Study phase

Target enrollment

86 participants

Primary outcome timeframe

48 hours post challenge and 24 hours and 48 hours post-challenge removal

Results posted on

2025-03-12

Participant Flow

All subjects receive the positive control, negative control and test product at the same time. The positive control is only applied at the first visit to ensure the subject responds appropriately to a sensitizer. From then on, both the negative control and test products are applied at the same times at different sites, and both sites are evaluated for a local reaction.

Participant milestones

Participant milestones
Measure	Test Article (Collagen Wound Dressing) and Negative Control (Distilled Water) Each subject will be treated with an occlusive patch of the test article (collagen dressing) and the negative control (distilled water) at the same time. During the induction phase of the study, the test article and negative control will be applied repetitively and continuously on one side of the paraspinal region of the back. Each application will be for approximately 48 hours (weekdays) or 72 hours (weekends) over three weeks for a total of 9 applications. During a subsequent challenge phase at least 10 days after the induction phase, the test article and negative control will be applied for 48 hours. The application sites of the subject will be evaluated at approximately 30 minutes, 24 hours, and 48 hours after removal of the test article and negative control.
Overall Study STARTED	86
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Article (Collagen Wound Dressing) and Negative Control (Distilled Water) Each subject will be treated with an occlusive patch of the test article (collagen dressing) and the negative control (distilled water) at the same time. During the induction phase of the study, the test article and negative control will be applied repetitively and continuously on one side of the paraspinal region of the back. Each application will be for approximately 48 hours (weekdays) or 72 hours (weekends) over three weeks for a total of 9 applications. During a subsequent challenge phase at least 10 days after the induction phase, the test article and negative control will be applied for 48 hours. The application sites of the subject will be evaluated at approximately 30 minutes, 24 hours, and 48 hours after removal of the test article and negative control.
Overall Study Did not show for first visit	10
Overall Study Lost to Follow-up	12
Overall Study Physician Decision	7

Baseline Characteristics

HRIPT for Collagen Dressing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Collagen Wound Dressing With Positive and Negative Controls n=57 Participants Application of test dressing, 0.5% sodium lauryl sulfate in distilled water, and distilled water on areas of the back or upper arm. ColActive Plus Collagen Matrix Dressing: Induction phase: Test article applied with Hill Top chamber every 48+ hours over 3 weeks. Rest phase: 10-day rest period with no application. Challenge phase: Test article applied for 48 hours and evaluated through 48 hours post removal. The positive control is evaluated at Induction 1 only. The negative control is applied following the same schedule as the test article.
Age, Continuous	48 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	18 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	10 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	11 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	14 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	4 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants
Fitzpatrick Skin Type I - always burn, does not tan	3 Participants n=5 Participants
Fitzpatrick Skin Type II - burn easily, tan slightly	14 Participants n=5 Participants
Fitzpatrick Skin Type III - burn moderately, tan progressively	10 Participants n=5 Participants
Fitzpatrick Skin Type IV - burn a little, always tan	13 Participants n=5 Participants
Fitzpatrick Skin Type V - rarely burn, tan intensely	17 Participants n=5 Participants
Fitzpatrick Skin Type VI - never burn, tan very intensely	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours post challenge and 24 hours and 48 hours post-challenge removal

Outcome measures

Outcome measures
Measure	Test Article (Collagen Wound Dressing) n=57 Skin sites Application of test dressing to test site using a 25-mm Hill Top Chamber. One test dressing will be applied directly to the test site (intrascapular region or upper arm) of the subject at each planned exposure.	Negative Control (Distilled Water) n=57 Skin sites Application of distilled water to test site using a 25-mm Hill Top Chamber. One negative control will be applied directly to the same test site (intrascapular region or upper arm) of the subject throughout the study following the same protocol as the test product.	Positive Control (0.5% Sodium Lauryl Sulfate) Application of 0.5% sodium lauryl sulfate to test site using a 25-mm Hill Top Chamber. One positive control will be applied directly to a test site (intrascapular region or upper arm) of the subject and will only be applied for Induction 1 (the first 48 hours).
Skin Sensitization Reaction Using Berger and Bowman Scale Mean score at 48 hours post challenge	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Skin Sensitization Reaction Using Berger and Bowman Scale Mean score at 24 hours post challenge removal	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Skin Sensitization Reaction Using Berger and Bowman Scale Mean score at 48 hours post-challenge removal	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 48-72 hours for 1 (positive control) or 9 (negative control and test) applications

Population: Assessment of the positive control was only planned post-application #1 but was also performed post-application #2.

Assessment of irritation based on the Berger and Bowman scale: Numeric Scores 0 = No evidence of irritation 1. = Minimal erythema, barely perceptible 2. = Moderate erythema, readily visible; or minimal edema; or minimal papular response 3. = Strong erythema; or erythema and papules 4. = Definite edema 5. = Erythema, edema and papules 6. = Vesicular eruption 7. = Strong reaction spreading beyond test site Letter Grades (always upper case) A = Slight glazed appearance B = Marked glazing C = Glazing with peeling and cracking F = Glazing with fissures G = Film of dried serous exudate covering all or a portion of the patch site H = Small petechial erosions and/or scabs Positive control should show a response and negative control should not show a response.

Outcome measures

Outcome measures
Measure	Test Article (Collagen Wound Dressing) n=57 Skin sites Application of test dressing to test site using a 25-mm Hill Top Chamber. One test dressing will be applied directly to the test site (intrascapular region or upper arm) of the subject at each planned exposure.	Negative Control (Distilled Water) n=57 Skin sites Application of distilled water to test site using a 25-mm Hill Top Chamber. One negative control will be applied directly to the same test site (intrascapular region or upper arm) of the subject throughout the study following the same protocol as the test product.	Positive Control (0.5% Sodium Lauryl Sulfate) n=57 Skin sites Application of 0.5% sodium lauryl sulfate to test site using a 25-mm Hill Top Chamber. One positive control will be applied directly to a test site (intrascapular region or upper arm) of the subject and will only be applied for Induction 1 (the first 48 hours).
Induction Phase Skin Response Post-application 2	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	0.5 score on a scale Interval 0.0 to 2.0
Induction Phase Skin Response Post-application 1	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	0.6 score on a scale Interval 0.0 to 3.0
Induction Phase Skin Response Post-application 3	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Induction Phase Skin Response Post-application 4	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Induction Phase Skin Response Post-application 5	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Induction Phase Skin Response Post-application 6	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Induction Phase Skin Response Post-application 7	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Induction Phase Skin Response Post-application 8	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—
Induction Phase Skin Response Post-application 9	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0	—

Adverse Events

Test Article (Collagen Wound Dressing) and Negative Control (Distilled Water)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Article (Collagen Wound Dressing) and Negative Control (Distilled Water) n=86 participants at risk Each subject will be treated with an occlusive patch of the test article (collagen dressing) and the negative control (distilled water) at the same time. During the induction phase of the study, the test article and negative control will be applied repetitively and continuously on one side of the paraspinal region of the back. Each application will be for approximately 48 hours (weekdays) or 72 hours (weekends) over three weeks for a total of 9 applications. During a subsequent challenge phase at least 10 days after the induction phase, the test article and negative control will be applied for 48 hours. The application sites of the subject will be evaluated at approximately 30 minutes, 24 hours, and 48 hours after removal of the test article and negative control.
General disorders headache and stomach pain	1.2% 1/86 • Number of events 1 • Adverse events were collected for the duration of the study, ~5 weeks. Adverse event is presented for all subjects by subject since the event was systemic in nature. Each subject received each treatment (test, positive control, and negative control) at a different skin site over the same study period.

Additional Information

Director of Regulatory Affairs

Covalon Technologies Inc.

Phone: 888-236-4944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place