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

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: NCT00836147
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : September 28, 2010
Sponsor:
Information provided by:
Renovo

Tracking Information
First Submitted Date  ICMJE February 3, 2009
First Posted Date  ICMJE February 4, 2009
Last Update Posted Date September 28, 2010
Study Start Date  ICMJE February 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
Keloid recurrance [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
Frequency of adverse events [ 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 Exploratory Study of the Efficacy and Safety of Juvista 250ng When Administered Following Excision of Ear Lobe Keloids
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Keloid
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: 1
    250 ng dose
    Intervention: Drug: Avotermin (Juvista)
  • Active Comparator: 2
    250 ng dose
    Intervention: Drug: Placebo
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
Actual Enrollment  ICMJE
 (submitted: February 3, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
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 NCT00836147
Other Study ID Numbers  ICMJE RN1001-0107
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. Leroy Young, MD Body Aesthetic Plastic Surgery and Skincare Center, St Louis, Missori, United States
PRS Account Renovo
Verification Date September 2010

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