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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06271993
Other study ID # 23-233
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2024
Est. completion date March 15, 2024

Study information

Verified date February 2024
Source Covalon Technologies Inc.
Contact Ashley Glavis
Phone 424-307-5900
Email Ashley.Glavis@ALSGlobal.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 15, 2024
Est. primary completion date February 16, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States ALS Beauty and Personal Care Torrance California

Sponsors (2)

Lead Sponsor Collaborator
Covalon Technologies Inc. ALS Beauty and Personal Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wheal measurement The wheal of each test site will be measured in millimeters. A larger wheal is associated with sensitization. 15-20 minutes following application
Primary Wheal measurement The wheal of each test site will be measured in millimeters. A larger wheal is associated with sensitization. 6 hours (+/-30 minutes)
Primary Wheal measurement The wheal of each test site will be measured in millimeters. A larger wheal is associated with sensitization. 24-48 hours
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