Exploratory Study of the Efficacy and Safety of Juvista 250ng When Administered Following Excision of Ear Lobe Keloids

Keloid Clinical Trial

Official title:

A Single-centre, Double Blind, Randomised, Exploratory Study to Explore the Efficacy and Safety of Juvista 250ng/100µL/Linear cm When Administered Following Excision of Ear Lobe Keloids.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836147
• Other study ID #: RN1001-0107
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 3, 2009
• Last updated: September 27, 2010
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2010
• 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 explore the efficacy and safety of 250ng Juvista per Linear cm, administered by intradermal injection following the excision of ear lobe keloids. Keloids commonly occur after ear piercing and are usually bilateral.One ear lobe will be treated with Juvist and one with placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subjects aged 18-85 years who have given written informed consent.

• Subjects with bilateral ear lobe keloid scars of comparable size and 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.

• Subjects 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 subjects 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:

• Subjects 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.

• Subjects with a history of a bleeding disorder.

• Subjects 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.

• Subjects 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.

• Subjects with a history of malignancy in the last 5 years.

• Subjects with a history of hypersensitivity to any of the drugs or dressings used in this trial.

• Subjects 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.

• Subjects undergoing investigations or changes in management for an existing medical condition.

• Subjects who, in the opinion of the Investigator, are unlikely to complete the trial for whatever reason.

• Female subjects who are pregnant or lactating.

• Subjects 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]

• Subjects who are not able to undergo MRI scanning due to their medical history or physical condition.

• Subjects who have previously received treatment with Juvista (Avotermin).

Study Design

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

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• Avotermin (Juvista)
20 patients undergoing surgical revision of bilateral ear lobe keloids. Injecting intradermally 250ng/100µL/linear cm of the wound margin to one ear lobe and placebo into the other wound margin immediately after surgery and then 24hrs after wound closure.
• Placebo
20 patients undergoing surgical revision of bilateral ear lobe keloids. Injecting intradermally 250ng/100µL/linear cm of the wound margin to one ear lobe and placebo into the other wound margin immediately after surgery and then 24hrs 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	Keloid recurrance		12 months	No
Secondary	Frequency of adverse events		12 months	Yes