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Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

Primary Purpose

Cicatrix

Status

Unknown status

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Avotermin

About this trial

This is an interventional treatment trial for Cicatrix

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged 18-85 years who have provided written informed consent.
A body mass index between 15 and 35 kg/m2 .
Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
Subjects with linear scars that, in the opinion of the Investigator, are suitable for revision by excision and direct closure. The area of scar to be revised must be at least 5cm in length and have at least two comparable areas.
Subjects, who, in the opinion of the Investigator have stabilised, mature scars.

Exclusion Criteria:

Subjects who on direct questioning and physical examination have history or evidence of keloid scarring.
Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar.
Subjects with additional scars less than 3cm away from the area to be revised.
Subjects with a history of a bleeding disorder.
Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
Subjects who have had surgery in the area to be excised within one year of Day 0.
Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
Subjects who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
Subjects who are taking, or have taken, any investigational drugs including Juvista within 3 months prior to the screening visit.
Subjects who are taking regular, continuous, oral corticosteroid therapy.
Subjects who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits.
Subjects undergoing investigations or changes in management for an existing medical condition.
Subjects who are or who become pregnant up to and including Day 0 or who are lactating.
In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.

Sites / Locations

Renovo Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Arm Description

Complete Scar Excision

Staged Excision of scar

Outcomes

Primary Outcome Measures

Investigator scar assessment

Patient scar assessment

Independent scar assessment

Secondary Outcome Measures

Local tolerability

Adverse events

Full Information

NCT ID

NCT00432211

First Posted

February 6, 2007

Last Updated

February 3, 2009

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00432211

Brief Title

Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

Official Title

A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2006 (undefined)

Primary Completion Date

July 2008 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

5. Study Description

Brief Summary

This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following surgical scar revision. In addition, this study will compare the scar revision techniques of complete excision (excision of the entire scar during one surgical procedure) and staged excision (excision of the outmost segments and central core separately).

6. Conditions and Keywords

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

Cicatrix

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Complete Scar Excision

Arm Title

Arm Type

Placebo Comparator

Arm Description

Staged Excision of scar

Intervention Type

Drug

Intervention Name(s)

Avotermin

Intervention Description

Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration. Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration.

Primary Outcome Measure Information:

Title

Investigator scar assessment

Time Frame

up to 7 month visit

Title

Patient scar assessment

Time Frame

up to 7 month visit

Title

Independent scar assessment

Time Frame

up to month 7

Secondary Outcome Measure Information:

Title

Local tolerability

Time Frame

up to month 7

Title

Adverse events

Time Frame

up to month 7

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: Subjects aged 18-85 years who have provided written informed consent. A body mass index between 15 and 35 kg/m2 . Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose. Subjects with linear scars that, in the opinion of the Investigator, are suitable for revision by excision and direct closure. The area of scar to be revised must be at least 5cm in length and have at least two comparable areas. Subjects, who, in the opinion of the Investigator have stabilised, mature scars. Exclusion Criteria: Subjects who on direct questioning and physical examination have history or evidence of keloid scarring. Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar. Subjects with additional scars less than 3cm away from the area to be revised. Subjects with a history of a bleeding disorder. Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy. Subjects who have had surgery in the area to be excised within one year of Day 0. Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial. Subjects who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing. Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial. Subjects who are taking, or have taken, any investigational drugs including Juvista within 3 months prior to the screening visit. Subjects who are taking regular, continuous, oral corticosteroid therapy. Subjects who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits. Subjects undergoing investigations or changes in management for an existing medical condition. Subjects who are or who become pregnant up to and including Day 0 or who are lactating. In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D A McGrouther, FRCS MD

Organizational Affiliation

University of Manchester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renovo Clinical Trials Unit

City

Manchester

ZIP/Postal Code

M13 9XX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21701333

Citation

So K, McGrouther DA, Bush JA, Durani P, Taylor L, Skotny G, Mason T, Metcalfe A, O'Kane S, Ferguson MWJ. Avotermin for scar improvement following scar revision surgery: a randomized, double-blind, within-patient, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2011 Jul;128(1):163-172. doi: 10.1097/PRS.0b013e318217429b.

Results Reference

derived

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Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

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