SPT for Sensitization of Collagen Dressing (NCT06271993) | Clinical Trial Compass
CompletedNot Applicable
SPT for Sensitization of Collagen Dressing
United States27 participantsStarted 2024-02-08
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.