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Sponsored by: |
Renovo |
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Information provided by: | Renovo |
ClinicalTrials.gov Identifier: | NCT00594581 |
This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.
Condition | Intervention | Phase |
---|---|---|
Cicatrix |
Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal Juvista (Avotermin) in Male Subjects Aged 18-45 Years |
Enrollment: | 71 |
Study Start Date: | October 2003 |
Study Completion Date: | March 2005 |
Arms | Assigned Interventions |
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1: Active Comparator
Juvista (avotermin) 50ng/100μl/linear cm wound margin
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Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)
Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin
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2: Active Comparator
Juvista (avotermin) at 200ng/100μl/linear cm
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Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)
Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Renovo ( Mark Cooper, SVP of Clinical Operations ) |
Study ID Numbers: | RN1001-319-1011 |
Study First Received: | December 11, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00594581 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
cicatrix, scarring, TGF-beta3, avotermin, Juvista |
Skin Diseases Healthy Cicatrix |