A double blind, placebo controlled trial to investigate the efficacy and safety of two concentrations of Juvidex in accelerating the healing of split thickness skin graft donor sites using different dosing regimes - Juvidex - SGDS

• Conditions: Acceleration of split thickness skin graft donor sites; MedDRA version: 9.1Level: PTClassification code 10036892Term: Promotion of wound healing

• Registration Number: EUCTR2007-004155-11-GB
• Lead Sponsor: Renovo Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

1. Subjects aged 18-85 years who have given written informed consent

2. A body mass index between 18-35 calculated using Quetelets index

3. Subjects with, in the opinion of the investigator, clinically acceptable results for the laboratory tests and ECG as specified in the trial protocol. All laboratory tests must be performed within 28 days of the first trial dose administration

4. Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least screening visit until 1 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.
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

1. Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring

2. Subjects with tattoos, birthmarks, moles or previous scars within 3cm of the area to be investigated during the trial

3. Afro-carribean subjects because of their increased susceptibility to hypertrophic and keloid scarring

4. Subjects who have had surgery in the area to be investigated within 1 year of the first dosing day

5. 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 the trial

6.Subjects with any clinically significant medical condition or history of any condition that would impair wound healing, including:
(a) subjects with renal impairment (CLcr < 80/ml/min)
(b) significant hepatic impairment (LFTs>3 times upper limit of normal)
(c) Congestive heart failure with a classification of >2 (NYHA classification)
(d) History of myocardial infarction, ischaemic heart disease (or presenting with symptoms or signs compatibile with ischaemic heart disease), coronary vasospasm or peripheral vascular disease
(e) Subjects with significant cerebrovascular disease including a history of stroke, transient ischaemic attacks or haemorrhage
(f) Malignancy (unless treated and disease-free for 5 years)
(g) Autoimmune disease (including active rheumatoid arthritis), immunosupression (oral corticosteroids) or chemotherapy within the last 12 months
(h) uncontrolled hypertension SBP>180mmHg, DBP>95mmHG
(i) Diabetes (except diet controlled)
(j) significant respiratory disease

(7) subjects with a history of clinically relevant allergy, hypersensitivity, angioedema or anaphylaxis

(8) Subjects with a progressive neurological condition including Parkinson's disease, Alzheimer's disease and uncontrolled epilepsy

(9) Subjects with a history of chronic viral infection (Hepatitis, HIV) or ongoing active infection

(10) Subjects with bleeding disorders including haemophilia, purpura or thrombocytopenia or receiving anticoagulants (e.g. warfarin, coumadin)

(11) Subjects who have taken any investigational product in the 12 months prior to first trial dose administration

(12) Subjects undergoing investigations or changes in management for an exisiting medical condition

(13) Subjects with a history of substance abuse or dedpendency (history of recreational use of cannabis is acceptable assuming a negative urine test for cannabis at screen). Subjects who have had a history of alcohol abuse but have been dependency free for 12 months will still be eligible.

(14) Subjects with any condition or serious illness which in the opinion of the investigator would intefere with study participation

(15) Subjects with ongoing psychiatric condition requiring treatment or psychosis

(16) Female subjects who are breast feeding or intending to become pregnanct or breast feed during the study

(17) Femal subjects who have had any change in their oral contraceptive medication in the 2 months prior to day 0, or anticipate any change during study participation

Study & Design

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