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

NCT00432211 | Unknown Phase 2

• 1 other identifier: RN1001-319-1009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Cicatrix

Outcome Measures

Primary Outcomes (3)

• Investigator scar assessment

  up to 7 month visit

• Patient scar assessment

  up to 7 month visit

• Independent scar assessment

  up to month 7

Secondary Outcomes (2)

• Local tolerability

  up to month 7

• Adverse events

  up to month 7

Study Arms (2)

1

PLACEBO COMPARATOR

Complete Scar Excision

Drug: Avotermin

2

PLACEBO COMPARATOR

Staged Excision of scar

Drug: Avotermin

Interventions

Avotermin DRUG

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo Clinical Trials Unit

Manchester, M13 9XX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21701333 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, human

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• D A McGrouther, FRCS MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 7, 2007
• Study Start: May 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2012
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

GB (1)