HRIPT for Collagen Dressing

Human Repeat Insult Patch Test (HRIPT): Assessment of Primary and Cumulative Skin Irritation and Skin Sensitization of a Product, Under Controlled and Maximized Conditions

The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site.

Study Overview

• Status: Completed
• Conditions: Skin Sensitisation
• Intervention / Treatment: Device: ColActive Plus Collagen Matrix Dressing

Detailed Description

Approximately 75 healthy subjects satisfying all criteria listed below will be enrolled to complete the study with a minimum of 50 subjects. The test product will be applied on the 25-millimeter Hill Top Chamber®, which will be applied directly to the test site. The positive control will be applied to each subject for the first 48 hours only, and the negative control will be applied throughout the study along with the test product. Enough product will be used to cover the chamber. The procedure involves occlusive patching of the test product and control(s) for a minimum of 48 hours followed by an assessment. The procedure will be repeated until a series of 9 consecutive 48-hour exposures have been made over 3 consecutive weeks. This induction phase is followed by an approximate two-week rest period. The challenge phase consists of a challenge or test dose applied once to a previously unexposed test site. Clinical staff will remove the patches 48 hours post-application. Reactions will be scored 30 minutes post-removal, 24-hours post-removal, and 48-hours post-removal. Skin response at each application site will be evaluated according to the Berger and Bowman Scale.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90501
      • ALS Beauty and Personal Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: 18-70
2. Sex: Male & Female
3. Fitzpatrick: I-V, minimum 10% of panel Fitzpatrick V.
4. Individuals who will be able to read, understand and give an informed consent relating to the study they are participating in.
5. Individuals who will be free of any dermatological or systemic disorder, which in the Investigator's opinion, could interfere with the study results.
6. Individuals who will be in general good health and who will complete a preliminary medical history form mandated by the testing facility.
7. Individuals who will be able to and agree to cooperate with the Investigator and clinical staff.
8. Individuals who will agree to have test products applied in accordance with the protocol and are able to complete the full course of the study.
9. Individuals who have not participated in a similar study in the past 30 days.
10. Individuals who agree to refrain from sun tanning/bathing and prolonged exposure to sunlight (outdoors).
11. Female volunteers who are willing to undergo a urine pregnancy test.
12. Individuals who agree to not change their current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study.

Exclusion Criteria:

1. Individuals who are currently taking any medications (topical or systemic) that may mask or interfere with the test results (specifically, corticosteroids, topical and/or systemic [except nasal steroids], non steroidal anti-inflammatory drugs [e.g. ibuprofen, Advil, Motrin, aspirin > 325mg/day], antihistamines, and topical/oral immunosuppressive medications). Subjects must refrain from using any topical/oral anti-inflammatory medications during the length of the study (6 weeks).
2. Individuals who have a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., systemic lupus erythematosus, rheumatoid arthritis, HIV positive).
3. Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
4. Individuals who have damaged skin in close proximity to test sites (e.g., sunburn, uneven skin pigmentation, tattoos, scars, excessive hair, active acne papules or other disfigurations).
5. Individuals who control their diabetes using insulin.
6. Individuals with any history, which in the Investigator's opinion, indicates the potential for harm to the subject or places the validity of the study in jeopardy.
7. Female volunteers who indicate that they are pregnant or are planning to become pregnant or nursing.
8. Individuals with a known history of hypersensitivity to any cosmetics, personal care products, fragrances, and/or adhesives.
9. Employees of ALS.
10. Individuals with a known fish allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Collagen wound dressing with positive and negative controls; Application of test dressing, 0.5% sodium lauryl sulfate in distilled water, and distilled water on areas of the back or upper arm.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Sensitization Reaction Using Berger and Bowman Scale	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	48 hours post challenge and 24 hours and 48 hours post-challenge removal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction Phase Skin Response	Assessment of irritation based on the Berger and Bowman scale: Numeric Scores 0 = No evidence of irritation; = Minimal erythema, barely perceptible; = Moderate erythema, readily visible; or minimal edema; or minimal papular response; = Strong erythema; or erythema and papules; = Definite edema; = Erythema, edema and papules; = Vesicular eruption; = 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.	Every 48-72 hours for 1 (positive control) or 9 (negative control and test) applications

Collaborators and Investigators

• Sponsor: Covalon Technologies Inc.
• Collaborators: ALS Beauty and Personal Care
• Investigators: Principal Investigator: Jordan DeSantis, MHI, BS, ALS

Publications and helpful links

General Publications

• Bowman JP, Berger RS, Mills OH, Kligman AM, Stoudemayer T. The 21-day human cumulative irritation test can be reduced to 14 days without loss of sensitivity. J Cosmet Sci. 2003 Sep-Oct;54(5):443-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 23-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No