Status:
COMPLETED
Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Wound Healing
Eligibility:
MALE
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the accelerated-healing potential of injection or injection plus topical application of Juvista to minor split skin grafts (SSG).
Detailed Description
Subjects were allocated into three groups (Group 1, Group 2 and Group 3) with all subjects receiving two 3cm2 SSG donor sites, one to each side of the lower back. Before wounding on Day 0, each site w...
Eligibility Criteria
Inclusion
- Clinically healthy, male subjects aged 18-85 years
- Weight between 40 and 150kg or a BMI within the permitted range for their height using Quetelet's index, 15-55 kg/m2. Weight (kg)/height (m)2.
Exclusion
- Subjects who had a history or evidence of hypertrophic or keloid scarring or had tattoos or previous scars in the area of the prospective SSG donor sites
- Subjects who had received surgery to the area of the lower back/buttocks in the previous 12 months
- Afro-Caribbean subjects were excluded because of their increased susceptibility to hypertrophic and keloid scarring
- Subjects who had evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, immunomediated conditions, skin diseases and allergies (such as clinically significant eczema
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine, allergy to surgical dressings used in this trial or to any excipients or vehicle in the formulation or delivery vehicle
- Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination
- Subjects who were receiving or had received certain prescribed drugs in the 4 weeks prior to Day 0, particularly topical or systemic steroids, anti- inflammatory, anti-coagulants, antiproliferative drugs and antibiotics. Certain drugs not excluded in this trial included over-the-counter analgesics, including paracetamol and codeine, vitamin and mineral supplements, and cold remedies. If antibiotics were required after Day 0 (e.g., for cases of wound infection), this did not result in the exclusion of affected subjects from the study
- Subjects who had taken part in a clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not.
- Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness
- Subjects who smoked more than 20 cigarettes a day
- Subjects who drank more than 28 units of alcohol per week (1 unit = ½ pint of beer \[285ml\], 25ml of spirits or 1 glass of wine)
- Subjects who demonstrated evidence of drug abuse
- Subjects who were known to have or have had serum hepatitis and those who are carriers of the hepatitis B surface antigen or hepatitis C antibody (Subjects with previous vaccination against hepatitis B were not excluded per se)
- Subjects who were known to have, or have had, serum hepatitis and those who were carriers of the hepatitis B core antibody with less than 10 units per litre of anti-hepatitis B (unless deemed NOT to be a carrier of hepatitis B after testing by the Public Health Laboratory)
- Subjects who had previously tested positive for HIV antibodies or who admitted to belonging to a high-risk group
- A subject who, in the opinion of the Investigator, was unlikely to complete the trial for whatever reason
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00984503
Start Date
October 1 2003
End Date
January 1 2006
Last Update
September 25 2009
Active Locations (1)
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1
Renovo
Manchester, United Kingdom, M13 9XX