Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions

Study Overview
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Brief Summary
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This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.

Official Title
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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

Conditions
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Cicatrix

Intervention / Treatment
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* Drug: Avotermin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Avotermin 5ng/100μL/linear cm wound margin | Drug: Avotermin<br>* A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.<br>* Other names: Juvista, RN1001, transforming growth factor beta 3;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Matched to avotermin dosage strength<br>* Other names: None applicable;|
| Experimental: 3<br>Avotermin 50ng/100μL/linear cm wound margin | Drug: Avotermin<br>* A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.<br>* Other names: Juvista, RN1001, transforming growth factor beta 3;|
| Placebo Comparator: 4<br>Placebo matched to avotermin 50ng/100μL/linear cm | Drug: Placebo<br>* Matched to avotermin dosage strength<br>* Other names: None applicable;|
| Experimental: 5<br>Avotermin 200ng/100μL/linear cm | Drug: Avotermin<br>* A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.<br>* Other names: Juvista, RN1001, transforming growth factor beta 3;|
| Placebo Comparator: 6<br>Placebo matched to avotermin 200ng/100μL/linear cm | Drug: Placebo<br>* Matched to avotermin dosage strength<br>* Other names: None applicable;|
| Experimental: 7<br>Avotermin 500ng/100μL/linear cm wound margin | Drug: Avotermin<br>* A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.<br>* Other names: Juvista, RN1001, transforming growth factor beta 3;|
| Placebo Comparator: 8<br>Placebo matched to avotermin 500ng/100μL/linear cm | Drug: Placebo<br>* Matched to avotermin dosage strength<br>* Other names: None applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: adverse events, local tolerability |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3