RN1001(Avotermin) in Scar Improvement Following Breast Augmentation

A Double Blind, Within Subject, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Female Subjects Undergoing Bilateral Breast Augmentation

This will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery. Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl of placebo solution per linear centimetre intradermally into both margins of their other breast wound. The allocation of treatment to wound (left or right) will be randomised and double blind.

Study Overview

• Status: Completed
• Conditions: Cicatrix; Mammaplasty
• Intervention / Treatment: Drug: Avotermin

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT9 6AF
    • The Fitzwilliam Clinic
  • Chester, United Kingdom, CH4 7QP
    • The Grosvenor Nuffield Hospital
  • Hull, United Kingdom, HU10 7AZ
    • Classic Hull & East Riding
  • Hull, United Kingdom, HU16 5FQ
    • Hull Nuffield Hospital
  • Manchester, United Kingdom, M13 9XX
    • Renovo CTU
  • Manchester, United Kingdom, M16 8AJ
    • BUPA Hospital
  • Warrington, United Kingdom, WA4 4LU
    • BUPA North Cheshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female subjects between 18 and 60 years of age undergoing bilateral breast augmentation through an infra-mammary fold incision who have given written informed consent.
• Weight between 50 and 150kg and a body mass index within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 15-55.
• 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 1 month post surgery.
• Subjects where the same implant position will be used for each breast; the implants can be placed in sub-mammary or sub-pectoral pockets.
• Subjects where the same type and size of implant is to be used for each breast.
• Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol . All laboratory tests must be performed within 28 days prior to Day 0.

Exclusion Criteria:

• Subjects with significant breast asymmetry where this may produce a different length or site of wound, or where there will be a different post-operative tension on the wound.
• Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring.
• Subjects who have had surgery in the area to be incised within one year of Day 0.
• Subjects with a personal history of a bleeding disorder.
• Subjects with any history of breast malignancy.
• 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 RN1001 within 3 months prior to the screening visit.
• Subjects who are taking regular, continuous, oral corticosteroid therapy.
• 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.
• Subjects with diseases or conditions that could in the opinion of the Investigator interfere with the assessment of safety, tolerability and efficacy.
• In the opinion of the Investigator, a subject who is not likely to complete the trial for what ever reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Investigator scar assessment
Patient scar assessment
Independent scar assessment

Secondary Outcome Measures

Outcome Measure
Adverse events
Local tolerance

Collaborators and Investigators

• Sponsor: Renovo
• Investigators: Principal Investigator: David Whitby, BUPA Hospital Manchester

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: February 16, 2007
• First Submitted That Met QC Criteria: February 16, 2007
• First Posted (Estimate): February 19, 2007

Study Record Updates

• Last Update Posted (Estimate): August 14, 2008
• Last Update Submitted That Met QC Criteria: August 13, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: RN1001-319-1010