Juvista (Avotermin) in Breast Reduction Surgery Scars

This study has been terminated.
(Futility analysis undertaken, determined that study was underpowered.)
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00432328
First received: February 6, 2007
Last updated: January 12, 2009
Last verified: January 2009
  Purpose

Severe scarring is a common problem following breast reduction surgery, studies have shown that over 64% of patients develop a hypertrophic scar at three months after the operation. Scar severity can be influenced by a large number of factors including age, sex, skin thickness and tension, ethnicity and the position of the scar on the body. Therefore the most sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to compare bilateral wounds on the same individual. Bilateral breast reduction surgery provides an ideal model for a within patient evaluation of anti-scarring activity in wounds which develop into bad scars.

This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance applied to approximated wound margins following bilateral reduction mammaplasty.


Condition Intervention Phase
Mammaplasty
Cicatrix
Drug: Avotermin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Improvement of Scar Appearance in Patients Undergoing Bilateral Reduction Mammaplasty.

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • Investigator scar assessment
  • Patient scar assessment
  • Independent scar assessment

Secondary Outcome Measures:
  • Local tolerance
  • Adverse events

Estimated Enrollment: 39
Study Start Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients between 18 and 65 years of age undergoing bilateral reduction mammaplasty with anchor shaped incisions, who have given written informed consent.
  • Patients with a Body Mass Index of 15-32 kg/m2 inclusive.
  • Patients 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 1 month after administration of the trial investigational products.
  • Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.

Exclusion Criteria:

  • Patients with significant breast asymmetry that may result in asymmetrical operative incisions being made on the left and rights breasts.
  • Patients with breast asymmetry that may result in different post-operative tensions on the wounds of the left and right breasts.
  • Patients who have had surgery in the area to be incised within one year of trial surgery.
  • Patients with a history of a bleeding disorder.
  • Patients with a history of breast malignancy.
  • Patients with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the wounds or involves the areas to be examined in this trial.
  • Patients who on direct questioning and/or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
  • Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
  • Patients who are taking, or have taken, any investigational drugs in the 3 months prior to the screening visit.
  • Patients who are taking regular, continuous, oral corticosteroid therapy.
  • Patients undergoing investigations or changes in management for an existing medical condition.
  • Patients who are or who become pregnant up to and including the day of surgery or who are lactating.
  • Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety or efficacy of the investigational product.
  • Patients who, in the opinion of the Investigator, are not likely to complete the trial.
  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: NCT00432328

Locations
United Kingdom
Fitzwilliam Clinic
Belfast, United Kingdom, BT9 6AF
Selly Oak Hospital
Birmingham, United Kingdom, B29 6JD
Queen Victoria Hospital
East Grinstead, United Kingdom, RH19 3DZ
Royal Victoria Infirmary
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Odstock Centre for Burns & Plastic Surgery, Salisbury District Hospital
Salisbury, United Kingdom, SP2 8BJ
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: Philip Gilbert, FDSRCS FRCS Queen Victoria Hospital, East Grinstead
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00432328     History of Changes
Other Study ID Numbers: RN1001-0041
Study First Received: February 6, 2007
Last Updated: January 12, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014