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 range18 Years – 85 Years
SexALL
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…
What they're measuring
1
Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars.