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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Renovo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00432211
First received: February 6, 2007
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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).


Condition Intervention Phase
Cicatrix
Drug: Avotermin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • Investigator scar assessment [ Time Frame: up to 7 month visit ] [ Designated as safety issue: No ]
  • Patient scar assessment [ Time Frame: up to 7 month visit ] [ Designated as safety issue: No ]
  • Independent scar assessment [ Time Frame: up to month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local tolerability [ Time Frame: up to month 7 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: up to month 7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Complete Scar Excision
Drug: Avotermin

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.

Placebo Comparator: 2
Staged Excision of scar
Drug: Avotermin

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.


  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432211

Locations
United Kingdom
Renovo Clinical Trials Unit
Manchester, United Kingdom, M13 9XX
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: D A McGrouther, FRCS MD University of Manchester
  More Information

No publications provided by Renovo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renovo Ltd
ClinicalTrials.gov Identifier: NCT00432211     History of Changes
Other Study ID Numbers: RN1001-319-1009
Study First Received: February 6, 2007
Last Updated: February 3, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 20, 2014