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

Primary Purpose

Keloid

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Avotermin (Juvista)
Placebo
Sponsored by
Renovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Body Aesthetic Plastic Surgery and Skincare Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

250 ng dose

250 ng dose

Outcomes

Primary Outcome Measures

Keloid recurrance

Secondary Outcome Measures

Frequency of adverse events

Full Information

First Posted
February 3, 2009
Last Updated
September 27, 2010
Sponsor
Renovo
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1. Study Identification

Unique Protocol Identification Number
NCT00836147
Brief Title
Exploratory Study of the Efficacy and Safety of Juvista 250ng When Administered Following Excision of Ear Lobe Keloids
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Renovo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
250 ng dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
250 ng dose
Intervention Type
Drug
Intervention Name(s)
Avotermin (Juvista)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Keloid recurrance
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. Leroy Young, MD
Organizational Affiliation
Body Aesthetic Plastic Surgery and Skincare Center, St Louis, Missori, United States
Official's Role
Principal Investigator
Facility Information:
Facility Name
Body Aesthetic Plastic Surgery and Skincare Center
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States

12. IPD Sharing Statement

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

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