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

NCT00984503 | Completed Phase 2

• 1 other identifier: RN1001-319-1007
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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).

Conditions

Cicatrix; Wound Healing

Keywords

Cicatrix; Scar; Wound healing; Avotermin; TGF beta 3; Juvista; RN1001

Outcome Measures

Primary Outcomes (1)

• To assess the accelerated-healing potential of injection or injection plus topical application of Juvista in a male population undergoing minor split skin grafts (SSG)

  Up to 12 months

Secondary Outcomes (3)

• To assess the local safety and toleration of injection of Juvista or injection and topical application of Juvista at the SSG donor site in a healthy male population

  Up to 12 months

• To assess systemic exposure following injection of Juvista or injection plus topical application of Juvista after SSG

  Up to 12 months

• To assess the anti-scarring potential of injection or injection and topical application of Juvista in a male population

  Up to 12 months

Study Arms (4)

Intradermal Juvista

EXPERIMENTAL

Drug: Avotermin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Intradermal and topical Juvista

EXPERIMENTAL

Drug: Avotermin

Intradermal and topical placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Avotermin DRUG

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

Also known as: Juvista, TGF beta 3, RN1001

Intradermal Juvista

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, human; Transforming Growth Factor beta3

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transforming Growth Factor beta; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; TGF-beta Superfamily Proteins; Proteins; Biological Factors

Study Officials

• Jonathan Duncan

  Renovo

  PRINCIPAL INVESTIGATOR

• Jeremy Bond

  Renovo

  PRINCIPAL INVESTIGATOR

• James Bush

  Renovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: October 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

GB (1)