Juvista (Avotermin) in Breast Reduction Surgery Scars

Cicatrix Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00432328
• Other study ID #: RN1001-0041
• Status: Terminated
• Phase: Phase 2
• First received: February 6, 2007
• Last updated: January 12, 2009
• Start date: October 2006

Study information

• Verified date: January 2009
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cicatrix
• Mammaplasty

Intervention

Drug:
• Avotermin

Locations

Country	Name	City	State
United Kingdom	Fitzwilliam Clinic	Belfast
United Kingdom	Selly Oak Hospital	Birmingham
United Kingdom	Queen Victoria Hospital	East Grinstead
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Odstock Centre for Burns & Plastic Surgery, Salisbury District Hospital	Salisbury

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator scar assessment
Primary	Patient scar assessment
Primary	Independent scar assessment
Secondary	Local tolerance
Secondary	Adverse events