Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions
This study has been completed.
Sponsor:
Renovo
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00627536
First received: February 22, 2008
Last updated: March 3, 2008
Last verified: March 2008
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Purpose
This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
| Condition | Intervention | Phase |
|---|---|---|
|
Cicatrix |
Drug: Avotermin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Renovo:
Primary Outcome Measures:
- Scar appearance [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: adverse events, local tolerability [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 39 |
| Study Start Date: | July 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Avotermin 5ng/100μL/linear cm wound margin
|
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Name: Juvista, RN1001, transforming growth factor beta 3
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
Matched to avotermin dosage strength
Other Name: None applicable
|
|
Experimental: 3
Avotermin 50ng/100μL/linear cm wound margin
|
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Name: Juvista, RN1001, transforming growth factor beta 3
|
|
Placebo Comparator: 4
Placebo matched to avotermin 50ng/100μL/linear cm
|
Drug: Placebo
Matched to avotermin dosage strength
Other Name: None applicable
|
|
Experimental: 5
Avotermin 200ng/100μL/linear cm
|
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Name: Juvista, RN1001, transforming growth factor beta 3
|
|
Placebo Comparator: 6
Placebo matched to avotermin 200ng/100μL/linear cm
|
Drug: Placebo
Matched to avotermin dosage strength
Other Name: None applicable
|
|
Experimental: 7
Avotermin 500ng/100μL/linear cm wound margin
|
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Name: Juvista, RN1001, transforming growth factor beta 3
|
|
Placebo Comparator: 8
Placebo matched to avotermin 500ng/100μL/linear cm
|
Drug: Placebo
Matched to avotermin dosage strength
Other Name: None applicable
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Mr Mark Cooper, Senior Vice President of Clinical Operations, Renovo |
| ClinicalTrials.gov Identifier: | NCT00627536 History of Changes |
| Other Study ID Numbers: | RN1001-0050 |
| Study First Received: | February 22, 2008 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Authority |
Keywords provided by Renovo:
|
scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3 |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes Mitogens |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013