A double blind, placebo controlled, randomised trial to investigate the efficacy of Juvista in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following scar revision surgery. - Juvista in the prevention or reduction of the resultant scar following scar revision surgery.
- Conditions
- 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: 6.1Level: PTClassification code 10039583
- Registration Number
- EUCTR2005-003889-42-GB
- Lead Sponsor
- Renovo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>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.
- Secondary Outcome Measures
Name Time Method