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| Sponsor: | Renovo |
|---|---|
| Information provided by: | Renovo |
| ClinicalTrials.gov Identifier: | NCT00836147 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Keloid |
Drug: Avotermin (Juvista) Drug: Placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
| Enrollment: | 20 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
250 ng dose
|
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.
|
|
Active Comparator: 2
250 ng dose
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
CLcr = 140 - age (years) x Weight (kg) 72 x serum creatinine mg/dL [ x 0.85 for females]
Contacts and Locations| United States, Missouri | |
| Body Aesthetic Plastic Surgery and Skincare Center | |
| St Louis, Missouri, United States, 63141 | |
| Principal Investigator: | V. Leroy Young, MD | Body Aesthetic Plastic Surgery and Skincare Center, St Louis, Missori, United States |
More Information
| Responsible Party: | Amanda Hilton Senior Clinical Research Manager, Renovo Ltd |
| ClinicalTrials.gov Identifier: | NCT00836147 History of Changes |
| Other Study ID Numbers: | RN1001-0107 |
| Study First Received: | February 3, 2009 |
| Last Updated: | September 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Keloid Collagen Diseases Connective Tissue Diseases |
Cicatrix Fibrosis Pathologic Processes |