Juvista in Scar Revision Surgery of Disfiguring Scars (NCT00742443) | Clinical Trial Compass
CompletedPhase 3
Juvista in Scar Revision Surgery of Disfiguring Scars
United States, Denmark, France350 participantsStarted 2008-12
Plain-language summary
This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placebo.
Who can participate
Age range
18 Years – 85 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:
* Patients aged 18-85 years who have provided written informed consent.
* BMI between 15 and 35 kg/m2
* Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
* If females of child bearing potential, patients must be using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose.
* The scar area to be revised is disfiguring. To be considered disfiguring for this trial scars must have at least one of the following characteristics.
* Scar area 13 or more cm in length.
* Scar area at least 0.6 cm wide at widest part.
* Surface contour of scar area elevated or depressed on palpation.
* Scar area adherent to underlying tissue.
* Skin hypo-or hyper-pigmented in an area exceeding 39cm2.
* Skin texture abnormal (irregular, atrophic, shiny, scaly, etc.) in an area exceeding 39cm2.
* The scar to be revised is at least 12 months old.
* The investigator considers that the appearance of the scar area to be revised can be improved with surgery alone.
* The scar area is linear and suitable for revision by excision and direct closure.
* The scar area to be revised is symmetrical in appearance around the mid-line.
* The scar area to be revised is between 7 and 20cm in length.
* The scar area to be revised runs along a flat surface which is in the same focal plane and suitable for accurate…
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.
What they're measuring
1
Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars.