Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

NCT ID: NCT00469235

Last Updated: 2009-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-05-31

Brief Summary

This trial will assess the safety and efficacy of 50 and 200ng 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.

Conditions

Keloid

Study Design

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

Study Groups

1

50ng dose group

Group Type: PLACEBO_COMPARATOR

Avotermin

Intervention Type: DRUG

10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

2

200ng dose group

Group Type: PLACEBO_COMPARATOR

Avotermin

Intervention Type: DRUG

10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

Interventions

Avotermin

10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

Intervention Type: DRUG

Eligibility Criteria

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.
• 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.

Exclusion Criteria

• Patients who have had ear lobe keloids treated with irradiation, cryosurgery, corticosteroids, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Renovo Ltd

Principal Investigators

Leroy Young, MD

Role: PRINCIPAL_INVESTIGATOR

Body Aesthetic Plastic Surgery and Skincare Centre

Locations

Body Aesthetic Plastic Surgery and Skincare Center

St Louis, Missouri, United States

Countries

United States

Other Identifiers

RN1001-0064

Identifier Type: -

Identifier Source: org_study_id