Cicatrix
Conditions
Keywords
scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3
Brief summary
This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
Interventions
DRUGAvotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
DRUGPlacebo
Matched to avotermin dosage strength
Sponsors
Renovo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females aged 18-85 years who had given written informed consent. * Subjects with a body mass index within 15 to 35 kg/m2. * Subjects with clinically acceptable results for the laboratory tests * Female subjects of child bearing potential who are using acceptable method(s) of contraception.
Exclusion criteria
* Subjects with history or evidence of hypertrophic or keloid scarring. * Subjects with tattoos or previous scars within 3cm of the area to be incised. * Subjects with prior surgery in the area to be incised within one year of the first dosing day. * Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy. * Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial. * Subjects with a clinically significant skin disorder that is chronic or currently active. * Subjects with any clinically significant medical condition or history that would impair wound healing. * Subjects with a history of drug hypersensitivity to any of the drugs or dressings used in this trial. * Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration. * Subjects who are taking regular, continuous, oral corticosteroid therapy. * Subjects undergoing investigations or changes in management for an existing medical condition. * Subjects with a history of drug abuse, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period. * Subjects who are considered unlikely to complete the trial for whatever reason. * Subjects with a clinically significant neurological impairment or disease. * Subjects with any active infection. * Subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scar appearance | 7 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety: adverse events, local tolerability | 7 months |
Countries
United Kingdom
Outcome results
None listed