Studio in doppio cieco, intra-soggetto, controllato con placebo, per valutare l?efficacia di Juvista (avotermina) unitamente alla revisione chirurgica delle cicatrici per il miglioramento delle cicatrici deturpanti. - Juvista in scar revision surgery of disfiguring scars

• Conditions: Improvement of scar appereance; MedDRA version: 9.1Level: LLTClassification code 10039589Term: Scarring

• Registration Number: EUCTR2008-002124-28-IT
• Lead Sponsor: RENOVO LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-22
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

General Inclusion Criteria The following general inclusion criteria are required to ensure that the patients included in the trial are suitable for entry in terms of their general health and the provision of informed consent. - Patients aged 18-85 years who have provided written informed consent. - A body mass index between 15 and 35 kg/m2 (calculated using Quetelet?s index [weight (kg)/height m2] - Patients 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 of the first trial dose administration. - If females of child bearing potential, patients must be using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner. For ``Scar Specific Inclusion Criteria `` please refer to the Protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General Exclusion Criteria The general exclusion criteria are required to exclude patients whose medical history, ongoing conditions or lifestyle could affect the assessment of efficacy or safety during the trial. The following criteria exclude patients who have compromised healing rates which may impact on scarring and subsequent treatment assessment: - 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 including : *Significant rheumatoid arthritis. *Significant hepatic impairment (LFTs >3 times upper limit of normal). *Inadequately or uncontrolled congestive heart failure. *Currently active malignancy or history of any malignancy in the 5 years prior to the screening visit. *Immunosuppression or chemotherapy in the twelve months prior to the screening visit. *A history of radiotherapy to the study scar area. *Diabetes mellitus (unless controlled by diet and exercise alone). *A bleeding disorder or current use of anti-thrombotic therapy (aspirin, ticlopidine and clopidogrel are permitted). - Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula : *CLcr = (140-age (years)) x weight(kg)/ 72 x serum creatinine (mg/dL) { x 0.85 for females } - Patients with a skin disorder that is chronic or currently active. The following criteria exclude patients who may not complete the trial assessments or who have conditions which may interfere with the assessment of drug safety: - Patients who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits. - 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 within 3 months prior to the screening visit. - Patients undergoing investigations or changes in management for an existing medical condition (excluding the scar for revision). - Patients who are or who become pregnant up to and including Day 0 or who are lactating. - In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.For ``Scar Specific Exclusion Criteria `` please refer to the Protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the efficacy of Juvista (avotermin) in the improvement of scar appearance when administered intradermally to the approximated wound margins of patients following scar revision surgery of disfiguring scars.;Secondary Objective: To assess the safety and tolerance of Juvista (avotermin) when administered intradermally to the approximated wound margins of patients following scar revision surgery of disfiguring scars.;Primary end point(s): The primary trial endpoint is the improvement of Juvista treated scars compared with placebo treated scars at 12 months post-surgery as assessed by an independent expert clinical panel using a Global Scar Comparison Scale. The key secondary endpoint is the improvement of Juvista treated scars compared with placebo treated scars at 12 months post-surgery as assessed by the patient using a Global Scar Comparison Scale.