Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars - Full Text View

Sponsor:	Renovo
Information provided by:	Renovo
ClinicalTrials.gov Identifier:	NCT00469235

Purpose

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.

Condition	Intervention	Phase
Keloid	Drug: Avotermin	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Scars

Drug Information available for: Avotermin

U.S. FDA Resources

Further study details as provided by Renovo:

Primary Outcome Measures:

Frequency of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Keloid reoccurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	June 2007
Study Completion Date:	May 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 50ng dose group	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.
Placebo Comparator: 2 200ng dose group	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.

Arms

Assigned Interventions

Placebo Comparator: 1

50ng dose group

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.

Placebo Comparator: 2

200ng dose group

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469235

Locations

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

Sponsors and Collaborators

Renovo

Investigators

Principal Investigator:

Leroy Young, MD

Body Aesthetic Plastic Surgery and Skincare Centre

More Information

No publications provided

Responsible Party:	Renovo Ltd
ClinicalTrials.gov Identifier:	NCT00469235 History of Changes
Other Study ID Numbers:	RN1001-0064
Study First Received:	May 3, 2007
Last Updated:	September 15, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Keloid
Collagen Diseases
Connective Tissue Diseases

Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012