Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Renovo

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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