Patients undergoing scar revision surgery are left with scarring, which can vary from fine flat asymptomatic scars to hypertrophic scars. Studies show that these visible marks can cause emotional distress resulting in self-consciousness, loss of self-esteem, stigmatism and diminished quality of life. Scar revision relies on surgical technique to improve scars from complications following surgery, burns, trauma and injury. MedDRA version: 6.1 Level: PT Classification code 10039583
Conditions
Interventions
Product Name: Juvista
Product Code: RN1001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Avotermin
Current Sponsor code: RN1001
Other descriptive name: Recombinant Human Transformin
Sponsors
Renovo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects aged 18-85 years who have provided written informed consent A body mass index between 15 and 35 kg/m2 Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol. Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator Subjects with linear scars that are suitable for revision by excision and direct closure. Subjects who have stabilised, mature scars Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who have history or evidence of keloid scarring. Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar. Subjects with additional scars less than 3cm away from the area to be revised. Subjects with a history of a bleeding disorder. Subjects with diseases or conditions that could interfere with assessment of safety, tolerability or efficacy. Subjects who have had surgery in the area to be excised within one year of Day 0. Subjects with a skin disorder which could affect the healing of acute wounds. Subjects with evidence of past or present medical condition that would impair wound healing. Subjects with hypersensitivity to any drug or dressing in trial. Subjects who are taking, or have taken, any investigational drugs including Juvista within 3 months of screening. Subjects taking regular, continuous, oral corticosteroids. Subjects with psychiatric disorders. Subjects undergoing investigations or changes in management for an existing medical condition. Subjects who are or become pregnant up to and including Day 0 or who are lactating. Subjects who are not likely to complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of Juvista in the prevention or reduction of the resultant scar when applied to the approximated wound margins of subjects following scar revision surgery.;Secondary Objective: To assess the safety and tolerance of Juvista when applied to the approximated wound margins of subjects following scar revision surgery. To compare the surgical scar revision techniques of complete excision and staged excision.;Primary end point(s): The primary endpoint will be the Total Scar Score (ToScar) from the Independent External Scar Assessment Panel VAS scores following blinded review of scar photographs taken at each time trial point up to month 7. | — |
Countries
United Kingdom
Outcome results
None listed