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

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00836147
First received: February 3, 2009
Last updated: September 27, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Keloid
Drug: Avotermin (Juvista)
Drug: Placebo
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • Keloid recurrance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
250 ng dose
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.
Active Comparator: 2
250 ng dose
Drug: 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.

  Eligibility

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836147

Locations
United States, Missouri
Body Aesthetic Plastic Surgery and Skincare Center
St Louis, Missouri, United States, 63141
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: V. Leroy Young, MD Body Aesthetic Plastic Surgery and Skincare Center, St Louis, Missori, United States
  More Information

No publications provided

Responsible Party: Amanda Hilton Senior Clinical Research Manager, Renovo Ltd
ClinicalTrials.gov Identifier: NCT00836147     History of Changes
Other Study ID Numbers: RN1001-0107
Study First Received: February 3, 2009
Last Updated: September 27, 2010
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 July 23, 2014