Allergic Skin Reaction, Allergy Skin
Conditions
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.
Detailed 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.
Interventions
DEVICEColActivePlus 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.
Sponsors
ALS Beauty and Personal Care
Covalon Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wheal Measurement | 15-20 minutes following application | The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Collagen Wound Dressing With Positive and Negative Controls Application of test dressing, histamine, and saline with glycerin to volar forearm skin
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. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Not reactive to histamine | 5 | 5 | 5 |
Baseline characteristics
| Characteristic | Collagen Wound Dressing With Positive and Negative Controls |
|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 14 |
| Fitzpatrick Skin Type I - always burn, does not tan | 2 Participants |
| Fitzpatrick Skin Type II - burn easily, tan slightly | 6 Participants |
| Fitzpatrick Skin Type III - burn moderately, tan progressively | 4 Participants |
| Fitzpatrick Skin Type IV - burn a little, always tan | 6 Participants |
| Fitzpatrick Skin Type VI - never burn, tan very intensely | 0 Participants |
| Fitzpatrick Skin Type V - rarely burn, tan intensely | 4 Participants |
| Race/Ethnicity, Customized Race African American | 4 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants |
| Race/Ethnicity, Customized Race Caucasian | 4 Participants |
| Race/Ethnicity, Customized Race Hispanic | 8 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
Time frame: 15-20 minutes following application
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collagen Wound Dressing | Wheal Measurement | 0 mm |
| Positive Controls | Wheal Measurement | 7.91 mm |
| Negative Controls | Wheal Measurement | 0.32 mm |
Primary
Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
Time frame: 6 hours (+/-30 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collagen Wound Dressing | Wheal Measurement | 0 mm |
| Positive Controls | Wheal Measurement | 0.27 mm |
| Negative Controls | Wheal Measurement | 0.14 mm |
Primary
Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
Time frame: 24-48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collagen Wound Dressing | Wheal Measurement | 0 mm |
| Positive Controls | Wheal Measurement | 0 mm |
| Negative Controls | Wheal Measurement | 0 mm |