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Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women

Primary Purpose

Cicatrix

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Avotermin (Juvista)

Placebo

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Cicatrix, Scar, TGFβ3, Avotermin, Juvista, RN1001

Eligibility Criteria

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

Inclusion Criteria:

Males and females aged 18-85 years who have given written informed consent.
Subjects with a body mass index within 15-35 kg/m2 (Quetelet's index).

Exclusion Criteria:

Subjects with history or evidence of keloid scarring.
Subjects with tattoos or previous scars within 3cm of the area to be incised.
Subjects who had surgery in the area to be incised within one year of the first dosing day.
Subjects with history of a bleeding disorder or who were 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 was chronic or currently active.
Subjects with any clinically significant medical condition or history that would impair wound healing.
Subjects with history of hypersensitivity to any of the drugs or dressings used in this trial.
Subjects taking, or who have taken, any investigational product or who had participated in a clinical trial in the three months prior to first trial dose administration.
Subjects 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, methamphetamines, opiates or benzodiazepines during the screening period.
Subjects who, in the opinion of the investigator, were unlikely to complete the trial for whatever reason.
Subjects who had any clinically significant neurological impairment or disease.
Subjects with any active infection.
Subjects who are pregnant or lactating.

Sites / Locations

Clinical Trials Unit, Renovo

Outcomes

Primary Outcome Measures

To determine the optimal concentration and dose regimen of avotermim (Juvista) for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions.

Secondary Outcome Measures

To assess the safety and tolerance of avotermin (Juvista) when applied to the approximated wound margins of male and female subjects following surgical incisions.

Full Information

NCT ID

NCT00629811

First Posted

February 26, 2008

Last Updated

February 26, 2008

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00629811

Brief Title

Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women

Official Title

A Double-Blind, Placebo-Controlled, Randomised Dose Ranging Trial to Investigate the Efficacy of Two Different Dosing Regimens 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

February 2008

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total), giving four pairs of anatomically matched wound sites per subject. Each subject acted as their own control. One site from each anatomical wound pair was randomly treated with intradermally administered avotermin (Juvista:100μL per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1, 400μL per wound site) while the second site was a paired control, treated with Placebo (100μL per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1, 400μL per wound site). Wound margins for injection were defined as extending 0.5cm from either end of the incision. Four doses of avotermin (Juvista) were administered to each subject: 5ng, 50ng, 200ng and 500ng/100μL per linear cm; one dose to one wound site per anatomically matched pair of wounds. The second wound site from each anatomically matched pair of wounds was dosed with placebo. Allocation of treatment to wound-site pairs was randomised and double blinded. Primary objective To determine the optimal concentration and dose regimen of Juvista for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions. Secondary objective To assess the safety and tolerance of Juvista when applied to the approximated wound margins of male and female subjects following surgical incisions.

6. Conditions and Keywords

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

Cicatrix

Keywords

Cicatrix, Scar, TGFβ3, Avotermin, Juvista, RN1001

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Avotermin (Juvista)

Other Intervention Name(s)

Juvista, RN1001, transforming-growth factor beta 3, TGFβ3

Intervention Description

Intradermal avotermin administered to four wound sites per subject, one wound site per anatomically matched pair, according to the subject's assigned dose group: Group 1: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 1) Group 2: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 0) Each subject received four doses of active drug at concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site, one dose to one wound site per anatomically matched pair of wounds.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Reference therapy was Placebo (vehicle). On Day 0, the four sites randomised to receive Placebo were administered with a 100μL intradermal injection of Placebo. Subjects in Group 2 were dosed again on Day 0 at 10 to 30 minutes after wound closure. Subjects in Group 1 were dosed again on Day 1 at 24 (+/-4) hours after initial administration of drug.

Primary Outcome Measure Information:

Title

Time Frame

Post surgery: week 6 to Month 7

Secondary Outcome Measure Information:

Title

To assess the safety and tolerance of avotermin (Juvista) when applied to the approximated wound margins of male and female subjects following surgical incisions.

Time Frame

Day 0 (surgery) to Month 7 post surgery

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 have given written informed consent. Subjects with a body mass index within 15-35 kg/m2 (Quetelet's index). Exclusion Criteria: Subjects with history or evidence of keloid scarring. Subjects with tattoos or previous scars within 3cm of the area to be incised. Subjects who had surgery in the area to be incised within one year of the first dosing day. Subjects with history of a bleeding disorder or who were 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 was chronic or currently active. Subjects with any clinically significant medical condition or history that would impair wound healing. Subjects with history of hypersensitivity to any of the drugs or dressings used in this trial. Subjects taking, or who have taken, any investigational product or who had participated in a clinical trial in the three months prior to first trial dose administration. Subjects 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, methamphetamines, opiates or benzodiazepines during the screening period. Subjects who, in the opinion of the investigator, were unlikely to complete the trial for whatever reason. Subjects who had any 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

Clinical Trials Unit, Renovo

City

Manchester

ZIP/Postal Code

M139XX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

19362676

Citation

Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.

Results Reference

derived

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Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women

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