RN1001(Avotermin) in Scar Improvement Following Breast Augmentation

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00436449
First received: February 16, 2007
Last updated: August 13, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Mammaplasty
Cicatrix
Drug: Avotermin
Phase 2

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

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

Enrollment: 63
Study Start Date: December 2004
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00436449

Locations
United Kingdom
The Fitzwilliam Clinic
Belfast, United Kingdom, BT9 6AF
The Grosvenor Nuffield Hospital
Chester, United Kingdom, CH4 7QP
Classic Hull & East Riding
Hull, United Kingdom, HU10 7AZ
Hull Nuffield Hospital
Hull, United Kingdom, HU16 5FQ
BUPA Hospital
Manchester, United Kingdom, M16 8AJ
Renovo CTU
Manchester, United Kingdom, M13 9XX
BUPA North Cheshire Hospital
Warrington, United Kingdom, WA4 4LU
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: David Whitby BUPA Hospital Manchester
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00436449     History of Changes
Other Study ID Numbers: RN1001-319-1010
Study First Received: February 16, 2007
Last Updated: August 13, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 30, 2014