Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars
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ClinicalTrials.gov Identifier: NCT00469235 |
Recruitment Status :
Completed
First Posted : May 4, 2007
Last Update Posted : September 16, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keloid | Drug: Avotermin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | June 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
50ng dose group
|
Drug: Avotermin
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. |
Placebo Comparator: 2
200ng dose group
|
Drug: Avotermin
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. |
- Frequency of adverse events [ Time Frame: 3 months ]
- Keloid reoccurrence [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469235
United States, Missouri | |
Body Aesthetic Plastic Surgery and Skincare Center | |
St Louis, Missouri, United States, 63141 |
Principal Investigator: | Leroy Young, MD | Body Aesthetic Plastic Surgery and Skincare Centre |
Responsible Party: | Renovo Ltd |
ClinicalTrials.gov Identifier: | NCT00469235 |
Other Study ID Numbers: |
RN1001-0064 |
First Posted: | May 4, 2007 Key Record Dates |
Last Update Posted: | September 16, 2009 |
Last Verified: | September 2009 |
Keloid Collagen Diseases Connective Tissue Diseases |
Cicatrix Fibrosis Pathologic Processes |