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Sponsored by: |
Renovo |
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Information provided by: | Renovo |
ClinicalTrials.gov Identifier: | NCT00469235 |
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.
Condition | Intervention | Phase |
---|---|---|
Keloid |
Drug: Avotermin |
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, Rising Dose Tolerance Study to Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids. |
Estimated Enrollment: | 20 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
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. |
2: Placebo Comparator
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. |
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: | Leroy Young, MD | Body Aesthetic Plastic Surgery and Skincare Centre |
Responsible Party: | Renovo Ltd ( Renovo Ltd ) |
Study ID Numbers: | RN1001-0064 |
Study First Received: | May 3, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00469235 |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Collagen Diseases Keloid Connective Tissue Diseases Cicatrix |