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Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

Primary Purpose

Keloid

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Avotermin

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:

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.
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.

Exclusion Criteria:

Patients 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.
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.

Sites / Locations

Body Aesthetic Plastic Surgery and Skincare Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Arm Description

50ng dose group

200ng dose group

Outcomes

Primary Outcome Measures

Frequency of adverse events

Secondary Outcome Measures

Keloid reoccurrence

Full Information

NCT ID

NCT00469235

First Posted

May 3, 2007

Last Updated

September 15, 2009

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00469235

Brief Title

Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

Official Title

A Single-centre, Double Blind, Randomised, Rising Dose Tolerance Study to Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial will assess the safety and efficacy of 50 and 200ng 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

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

50ng dose group

Arm Title

Arm Type

Placebo Comparator

Arm Description

200ng dose group

Intervention Type

Drug

Intervention Name(s)

Avotermin

Intervention Description

10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure. 10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

Primary Outcome Measure Information:

Title

Frequency of adverse events

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Keloid reoccurrence

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

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. 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. Exclusion Criteria: Patients 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leroy Young, MD

Organizational Affiliation

Body Aesthetic Plastic Surgery and Skincare Centre

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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Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

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