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

NCT ID: NCT00984503

Last Updated: 2009-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2006-01-31

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 was randomised to receive either an intradermal injection of Juvista (50ng/100μl/cm2), an intradermal injection of Placebo (100μl/cm2) or no injection (Standard Care). After wounding, subjects allocated to Group 2 and Group 3 also received topical Juvista (100ng/200μl/cm2), topical Placebo (200μl/cm2) or Standard Care (Tegaderm dressing only). Topical Juvista and Placebo were held within a Granuflex ring dressing and sealed with a sterile Tegaderm dressing.

On Day 1, subjects in Group 2 and Group 3 received a further topical application of Juvista, Placebo or Standard Care according to the same treatment randomisation as Day 0.

Punch biopsy samples of healing SSG donor sites were harvested from Group 3 subjects on Day 3, 5, 7 or 10, and preserved for histological analysis.

The final study visit for Group 3 subjects was the day of the biopsy visit. Subjects in Group 1 and Group 2 underwent scar assessments at the first follow-up at Month 1 and at Months 2, 3, 4, 5, 6, 9 and 12.

Conditions

Cicatrix; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intradermal Juvista

Group Type: EXPERIMENTAL

Avotermin

Intervention Type: DRUG

Intradermal Juvista at 50ng/100μl/cm2 of SSG donor sites (3cm2) once just prior to wounding

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding

Intradermal and topical Juvista

Group Type: EXPERIMENTAL

Avotermin

Intervention Type: DRUG

Intradermal Juvista at 50ng/100μl/cm2 of SSG donor site once just prior to wounding, followed by topical Juvista at 100ng/200μl/cm2 after wounding and again at Day 1

Intradermal and topical placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1

Interventions

Avotermin

Intradermal Juvista at 50ng/100μl/cm2 of SSG donor sites (3cm2) once just prior to wounding

Intervention Type: DRUG

Placebo

Intradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding

Intervention Type: DRUG

Avotermin

Intradermal Juvista at 50ng/100μl/cm2 of SSG donor site once just prior to wounding, followed by topical Juvista at 100ng/200μl/cm2 after wounding and again at Day 1

Intervention Type: DRUG

Placebo

Intradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1

Intervention Type: DRUG

Other Intervention Names

Juvista; TGF beta 3; RN1001; Juvista; TGF beta 3; RN1001

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Renovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Renovo

Principal Investigators

Jonathan Duncan

Role: PRINCIPAL_INVESTIGATOR

Renovo

Jeremy Bond

Role: PRINCIPAL_INVESTIGATOR

Renovo

James Bush

Role: PRINCIPAL_INVESTIGATOR

Renovo

Locations

Renovo

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

RN1001-319-1007

Identifier Type: -

Identifier Source: org_study_id