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

Primary Purpose

Cicatrix

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Avotermin

Placebo

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Renovo Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Arm Description

Avotermin 5ng/100μL/linear cm wound margin

Placebo

Avotermin 50ng/100μL/linear cm wound margin

Placebo matched to avotermin 50ng/100μL/linear cm

Avotermin 200ng/100μL/linear cm

Placebo matched to avotermin 200ng/100μL/linear cm

Avotermin 500ng/100μL/linear cm wound margin

Placebo matched to avotermin 500ng/100μL/linear cm

Outcomes

Primary Outcome Measures

Scar appearance

Secondary Outcome Measures

Safety: adverse events, local tolerability

Full Information

NCT ID

NCT00627536

First Posted

February 22, 2008

Last Updated

March 3, 2008

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00627536

Brief Title

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

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cicatrix

Keywords

scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Avotermin 5ng/100μL/linear cm wound margin

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Experimental

Arm Description

Avotermin 50ng/100μL/linear cm wound margin

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo matched to avotermin 50ng/100μL/linear cm

Arm Title

Arm Type

Experimental

Arm Description

Avotermin 200ng/100μL/linear cm

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo matched to avotermin 200ng/100μL/linear cm

Arm Title

Arm Type

Experimental

Arm Description

Avotermin 500ng/100μL/linear cm wound margin

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo matched to avotermin 500ng/100μL/linear cm

Intervention Type

Drug

Intervention Name(s)

Avotermin

Other Intervention Name(s)

Juvista, RN1001, transforming growth factor beta 3

Intervention Description

A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

None applicable

Intervention Description

Matched to avotermin dosage strength

Primary Outcome Measure Information:

Title

Scar appearance

Time Frame

7 months

Secondary Outcome Measure Information:

Title

Safety: adverse events, local tolerability

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Bush, MBChB

Organizational Affiliation

Renovo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renovo Clinical Trials Unit

City

Manchester

ZIP/Postal Code

M139XX

Country

United Kingdom

12. IPD Sharing Statement

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

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