Allergy SkinNCT06271993
SPT for Sensitization of Collagen Dressing
A study testing ColActivePlus Collagen Matrix Dressing in people with Allergy Skin and Allergic Skin Reaction, run by Covalon Technologies Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy Skin, Allergic Skin Reaction
- What is being tested?
- ColActivePlus Collagen Matrix Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
ALS Beauty and Personal Care
Torrance, California, 90501
About this study
Official title: Skin Prick Test (SPT) for Skin Sensitization (Contact Allergy) of Test Product ColActive Plus Collagen Matrix Dressing
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.
Read the 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.
- Conditions
- Allergy Skin, Allergic Skin Reaction
- Being tested
- ColActivePlus Collagen Matrix Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColActivePlus Collagen Matrix DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Collagen wound dressing with positive and negative controls | Other | Application of test dressing, histamine, and saline with glycerin to volar forearm skin Receives: Device: ColActivePlus Collagen Matrix Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal Measurement
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
Measured: 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.
Measured: 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.
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start8 Feb 2024
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergy SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Covalon Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ALS Beauty and Personal Care
- Responsible party
- Sponsor
- Investigators
- Jordan DeSantis, MHI, BS, Principal investigator, ALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271993
- Sponsor's protocol ID
- 23-233
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Prick Test (SPT) for Skin Sensitization (Contact Allergy) of Test Product ColActive Plus Collagen Matrix Dressing
- ClinicalTrials.gov ID
- NCT06271993
- Acronym / sponsor ID
- 23-233
- Conditions
- Allergy Skin, Allergic Skin Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Covalon Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- ALS Beauty and Personal Care
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Collagen wound dressing with positive and negative controls | Other | Device: ColActivePlus Collagen Matrix DressingApplication of test dressing, histamine, and saline with glycerin to volar forearm skin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColActivePlus Collagen Matrix DressingThe 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. | Device | Collagen wound dressing with positive and negative controls |
Primary outcome
Wheal Measurement
Time frame: 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.
Wheal Measurement
Time frame: 6 hours (+/-30 minutes)
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
Wheal Measurement
Time frame: 24-48 hours
The wheal of each test site will be measured in millimeters. A larger wheal (≥3 mm) is associated with sensitization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan DeSantis, MHI, BS principal investigator
ALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColActivePlus Collagen Matrix Dressing in people with Allergy Skin and Allergic Skin Reaction, run by Covalon Technologies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wheal Measurement (time frame: 15-20 minutes following application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.