Safety of Juvista When Administered Following Excision of Ear Lobe Keloids (RN1001-0093)

A Single-centre, Double Blind, Randomised, Tolerance Study to Investigate the Safety of Juvista 500ng/100µL/Linear cm When Administered Following Excision of Ear Lobe Keloids.

This trial will assess the safety and efficacy of 500ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.

Study Overview

• Status: Completed
• Conditions: Keloid
• Intervention / Treatment: Drug: placebo; Drug: Avotermin

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Body Aesthetic Plastic Surgery and Skincare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18-85 years who have given written informed consent.
• Patients with bilateral ear lobe keloid scars suitable for surgical excision which will result in a single wound on each ear lobe no greater than 2cm long and restricted to the skin, fat and fibrous tissue of the ear lobe.
• Patients with, in the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 6.3.2). All laboratory tests must be performed within 28 days of the first trial dose administration.
• Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one 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.

Exclusion Criteria:

• Patients who have had ear lobe keloids treated with irradiation, cryosurgery, corticosteriods, or other pharmacological agents in the three months prior to the first trial dose administration.
• Patients with a history of a bleeding disorder.
• Patients who on direct questioning and/or physical examination have past or present evidence of eczema or psoriasis local to the site of administration, uncontrolled diabetes (fasting plasma glucose concentration consistently at or above 7.0mmol 1-1 (126 mg dl-1), severely immunocompromised patients and/or malignant skin tumours e.g. melanomas, squamous or basal cell carcinomas.
• Patients with a skin disorder, not related to the keloid disease, 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 this trial.
• Patients with a history of malignancy in the last 5 years.
• Patients with a history of hypersensitivity to any of the drugs or dressings used in this trial.
• Patients who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
• Patients undergoing investigations or changes in management for an existing medical condition.
• Patients who, in the opinion of the Investigator, are unlikely to complete the trial for whatever reason.
• Female patients who are pregnant or lactating.
• Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula.
• CLcr = (140-age (years)) x weight (kg)/ 72 x serum creatinine (mg/dL) { x 0.85 for females}
• Patients who are not able to undergo MRI scanning due to their medical history or Physical condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2	Drug: Avotermin; 10 patients undergoing surgical revision of bilateral keloids will be dosed with 500ng Juvista/100µL per cm of wound margin to one ear lobe and placebo to the other and followed up for three months after dosing to assess the local and systemic tolerability.
PLACEBO_COMPARATOR: 1; 500ng dose	Drug: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of Adverse events	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Keliod recurrence	12 months

Collaborators and Investigators

• Sponsor: Renovo
• Investigators: Principal Investigator: V V Young, MD, Body Aesthetic Plastic Surgery and Skincare Center

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (ESTIMATE): July 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 9, 2010
• Last Update Submitted That Met QC Criteria: March 8, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid
• Other Study ID Numbers: RN1001-0093