Clinical trial NCT00627536: Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions
Official title: A Double-Blind, Placebo-Controlled, Randomised Dose-Ranging Trial to Investigate the Efficacy of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cicatrix
Keywords: scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2008-03-03
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Scar appearance
timeFrame: 7 months
Secondary outcomes:
measure: Safety: adverse events, local tolerability
timeFrame: 7 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Renovo Clinical Trials Unit
Study officials:
affiliation: Renovo
name: James Bush, MBChB
role: PRINCIPAL_INVESTIGATOR
References: