Juvista in Scar Revision Surgery of Disfiguring Scars (Revise)

This is an interventional prevention trial for Cicatrix focused on measuring Scar Revision Read More

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.