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Sponsored by: |
Renovo |
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Information provided by: | Renovo |
ClinicalTrials.gov Identifier: | NCT00710333 |
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.
Condition | Intervention | Phase |
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Keloid |
Drug: Avotermin Drug: placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
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. |
Estimated Enrollment: | 10 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
500ng dose
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Drug: placebo
placebo
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2: Experimental |
Drug: Avotermin
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.
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Body Aesthetic Plastic Surgery and Skincare Center | |
St Louis, Missouri, United States, 63141 |
Principal Investigator: | V V Young, MD | Body Aesthetic Plastic Surgery and Skincare Center |
Responsible Party: | Renovo Ltd ( Amanda Hilton Senior Clinical Research Manager ) |
Study ID Numbers: | RN1001-0093 |
Study First Received: | July 3, 2008 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00710333 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Collagen Diseases Keloid Connective Tissue Diseases Cicatrix |
Skin Diseases Collagen Diseases Keloid Connective Tissue Diseases Cicatrix |