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Safety of Juvista When Administered Following Excision of Ear Lobe Keloids (RN1001-0093)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00710333
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
Renovo

Tracking Information
First Submitted Date  ICMJE July 3, 2008
First Posted Date  ICMJE July 4, 2008
Last Update Posted Date March 9, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
Frequency of Adverse events [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
Keliod recurrence [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Juvista When Administered Following Excision of Ear Lobe Keloids
Official Title  ICMJE A Single-centre, Double Blind, Randomised, Tolerance Study to Investigate the Safety of Juvista 500ng/100µL/Linear cm When Administered Following Excision of Ear Lobe Keloids.
Brief Summary This trial will assess the safety and efficacy of 500ng 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Keloid
Intervention  ICMJE
  • Drug: Avotermin
    10 patients undergoing surgical revision of bilateral keloids will be dosed with 500ng Juvista/100µL per cm of wound margin to one ear lobe and placebo to the other and followed up for three months after dosing to assess the local and systemic tolerability.
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Placebo Comparator: 1
    500ng dose
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: Avotermin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 3, 2008)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (see Protocol Section 6.3.2). All laboratory tests must be performed within 28 days of the first trial dose administration.
  • 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. 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:

  • Patients who have had ear lobe keloids treated with irradiation, cryosurgery, corticosteriods, 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. 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}
  • Patients who are not able to undergo MRI scanning due to their medical history or Physical condition.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00710333
Other Study ID Numbers  ICMJE RN1001-0093
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amanda Hilton Senior Clinical Research Manager, Renovo Ltd
Study Sponsor  ICMJE Renovo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: V V Young, MD Body Aesthetic Plastic Surgery and Skincare Center
PRS Account Renovo
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP