HRIPT for Collagen Dressing

NCT06283173 | Completed Results FDA Device

• 1 other identifier: 23-401
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Sensitisation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Induction Phase Skin Response

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

Study Arms (1)

Collagen wound dressing with positive and negative controls

EXPERIMENTAL

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

Interventions

ColActive Plus Collagen Matrix Dressing DEVICE

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.

Collagen wound dressing with positive and negative controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70
• Sex: Male \& Female
• Fitzpatrick: I-V, minimum 10% of panel Fitzpatrick V.
• Individuals who will be able to read, understand and give an informed consent relating to the study they are participating in.
• Individuals who will be free of any dermatological or systemic disorder, which in the Investigator's opinion, could interfere with the study results.
• Individuals who will be in general good health and who will complete a preliminary medical history form mandated by the testing facility.
• Individuals who will be able to and agree to cooperate with the Investigator and clinical staff.
• 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.
• Individuals who have not participated in a similar study in the past 30 days.
• Individuals who agree to refrain from sun tanning/bathing and prolonged exposure to sunlight (outdoors).
• Female volunteers who are willing to undergo a urine pregnancy test.
• 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.

You may not qualify if:

• 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).
• 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).
• Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
• 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).
• Individuals who control their diabetes using insulin.
• 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.
• Female volunteers who indicate that they are pregnant or are planning to become pregnant or nursing.
• Individuals with a known history of hypersensitivity to any cosmetics, personal care products, fragrances, and/or adhesives.
• Employees of ALS.
• Individuals with a known fish allergy.

Sponsors & Collaborators

• Covalon Technologies Inc.: lead
• ALS Beauty and Personal Care: collaborator

Study Sites (1)

ALS Beauty and Personal Care

Torrance, California, 90501, United States

Location

Related Publications (1)

• 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.

  PMID: 14605686 BACKGROUND

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Covalon Technologies Inc.

customerservice@covalon.com

888-236-4944

Study Officials

• Jordan DeSantis, MHI, BS

  ALS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a single center, with no randomization or blinding, study design in 50 healthy adult subjects, age 18-70 years. Based on prior experience approximately 75 subjects will be enrolled to ensure 50 subjects complete the study.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: January 31, 2024
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)