SPT for Sensitization of Collagen Dressing

NCT06271993 | Completed Results FDA Device

• 1 other identifier: 23-233
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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: • Does the product induce any sensitization (contact allergy) after a skin prick using a UniTest PC (pain control) device in healthy human subjects? Participants will have the test product and both positive and negative controls applied, and skin response will be evaluated by an allergist at 15 minutes, 6 hours, and 24-48 hours post-application to see if sensitization occurs.

Conditions

Allergy Skin; Allergic Skin Reaction

Outcome Measures

Primary Outcomes (3)

• Wheal Measurement

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

  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.

  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.

  24-48 hours

Study Arms (1)

Collagen wound dressing with positive and negative controls

OTHER

Application of test dressing, histamine, and saline with glycerin to volar forearm skin

Device: ColActivePlus Collagen Matrix Dressing

Interventions

ColActivePlus Collagen Matrix Dressing DEVICE

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.

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).
• Individuals who are willing to refrain from wetting, wiping, cleanse, and covering the test sites (volar surface of the forearms) between the baseline and up to 48-hour time points.
• Female volunteers who are willing to undergo a urine pregnancy test.
• Individuals willing to refrain from vitamin C (Emergen-C), orange juice and vitamin water for the study duration and two days prior to the SPT test.

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).
• 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.
• Individuals that have a history of dermatographism.
• Individuals have a history of frequent skin irritation.
• 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

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 20 healthy adult subjects, age 18-70 years. Based on prior experience approximately 30 subjects will be enrolled to ensure 20 subjects complete the study.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: February 8, 2024
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)