Safety of Juvista When Administered Following Excision of Ear Lobe Keloids (RN1001-0093)
Primary Purpose
Keloid
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Avotermin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Keloid
Eligibility 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 (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.
Sites / Locations
- Body Aesthetic Plastic Surgery and Skincare Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
500ng dose
Outcomes
Primary Outcome Measures
Frequency of Adverse events
Secondary Outcome Measures
Keliod recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00710333
Brief Title
Safety of Juvista When Administered Following Excision of Ear Lobe Keloids
Acronym
RN1001-0093
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Renovo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
500ng dose
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Avotermin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Frequency of Adverse events
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Keliod recurrence
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V V Young, MD
Organizational Affiliation
Body Aesthetic Plastic Surgery and Skincare Center
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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Safety of Juvista When Administered Following Excision of Ear Lobe Keloids
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