Status:
COMPLETED
Juvista in Scar Revision Surgery of Disfiguring Scars
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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.
Detailed Description
Each year, over one hundred million people undergo elective or emergency surgery and are left with scarring. Of these, over half a million patients undergo scar revision surgery. These types of scars ...
Eligibility Criteria
Inclusion
- 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 medical photography.
- The scar is approved for entry into the trial by the Independent Expert Screening Panel.
- Exclusion Criteria
- Patients who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
- Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula :
- CLcr = (140-age (years)) x weight(kg)/ 72 x serum creatinine (mg/dL) {x 0.85 for females}
- Patients with a skin disorder that is chronic or currently active.
- Patients who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits.
- Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- Patients undergoing investigations or changes in management for an existing medical condition (excluding the scar for revision).
- Patients who are or who become pregnant up to and including Day 0 or who are lactating.
- In the opinion of the Investigator, a patient who is not likely to complete the trial.
- Patients who on direct questioning and physical examination have history or evidence of keloid scarring.
- Patients with scar areas for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar or difficulty in taking photographs.
- Patients with additional scars less than 3cm away from the area to be revised.
- Patients with scars that require revision using Z-plasty, W-plasty or any other such techniques.
- Patients who are involved in ongoing litigation in connection with the scar to be revised.
- Patients who have had surgery in the area to be excised within one year of Day 0.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00742443
Start Date
December 1 2008
End Date
February 1 2011
Last Update
March 3 2011
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
BodyAesthetic Research Center
St Louis, Missouri, United States, 63141
2
Grymer Privathospital
Aarhus, Denmark, 8200
3
Odense Universitetshopital
Odense, Denmark
4
Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C
Viruni, Denmark, 2830