Overview

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

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Renovo
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.