Clinical trial NCT00432328: Juvista (Avotermin) in Breast Reduction Surgery Scars
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mammaplasty
Cicatrix
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Investigator scar assessment
measure: Patient scar assessment
measure: Independent scar assessment
Secondary outcomes:
measure: Local tolerance
measure: Adverse events
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Fitzwilliam Clinic
city: Birmingham
country: United Kingdom
facility: Selly Oak Hospital
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Salisbury
country: United Kingdom
facility: Odstock Centre for Burns & Plastic Surgery, Salisbury District Hospital
Study officials:
affiliation: Queen Victoria Hospital, East Grinstead
name: Philip Gilbert, FDSRCS FRCS
role: PRINCIPAL_INVESTIGATOR
References: