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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00432328
Other study ID # RN1001-0041
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
See also
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Completed NCT00847795 - Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects. Phase 1/Phase 2
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Completed NCT00430326 - Juvista (Avotermin) in Scars Following Varicose Vein Removal Phase 2
Completed NCT00847925 - Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects Phase 1/Phase 2
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Completed NCT02985151 - Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy N/A
Completed NCT02340325 - FS2 Safety and Tolerability Study in Healthy Volunteers Phase 1
Active, not recruiting NCT00432211 - Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery. Phase 2
Completed NCT00978302 - Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista) Phase 1
Withdrawn NCT04034615 - The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars Phase 2