Acceleration of split thickness skin graft donor sites MedDRA version: 9.1 Level: PT Classification code 10036892 Term: Promotion of wound healing
Conditions
Interventions
Product Name: Juvidex
Product Code: RN1004
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intradermal us
Sponsors
Renovo Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of two concentrations of Juvidex with placebo on the healing of split thickness skin graft donor sites.;Secondary Objective: To assess the safety and tolerance of two concentrations of Juvidex when administered by intradermal injection and/or topically to split thickness skin graft donor sites. To compare the efficacyof placebo with standard care on the healing of split thickness skin graft donor sites.;Primary end point(s): The primary trial endpoint will be the time to complete wound closure (100% re-epithelialisation) at the skin graft donor site as assessed by the investigating physician. | — |
Countries
United Kingdom
Outcome results
None listed