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

Keloid Clinical Trial

Official title:

A Single-centre, Double Blind, Randomised, Rising Dose Tolerance Study to Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469235
• Other study ID #: RN1001-0064
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 3, 2007
• Last updated: September 15, 2009
• Start date: June 2007
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Body Aesthetic Plastic Surgery and Skincare Center	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events		3 months	Yes
Secondary	Keloid reoccurrence		12 months	No