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Sponsored by: |
Renovo |
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Information provided by: | Renovo |
ClinicalTrials.gov Identifier: | NCT00742443 |
This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placebo.
Condition | Intervention | Phase |
---|---|---|
Cicatrix |
Drug: Juvista (avotermin) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind, Within Patient, Placebo Controlled Trial to Confirm the Efficacy of Juvista (Avotermin) in Conjunction With Scar Revision Surgery for the Improvement of Disfiguring Scars. |
Estimated Enrollment: | 350 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Active versus Placebo within patient
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Drug: Juvista (avotermin)
100ng/100µL Juvista administered to each linear centimetre of the margins of one wound segment by intradermal injection immediately after and then 24h after wound closure versus 100μL of placebo administered to each linear centimetre of the margins of the other wound segment by intradermal injection immediately after and then 24h after wound closure
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2
Active vs. Placebo within patient
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Drug: Juvista (avotermin)
250ng/100µL Juvista administered to each linear centimetre of the margins of one wound segment by intradermal injection immediately after and then 24h after wound closure versus 100μL of placebo administered to each linear centimetre of the margins of the other wound segment by intradermal injection immediately after and then 24h after wound closure
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3
Active vs. Active within patient
|
Drug: Juvista (avotermin)
250ng/100µL Juvista administered to each linear centimetre of the margins of both wound segments by intradermal injection immediately after and then 24h after wound closure
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Each year, over one hundred million people undergo elective or emergency surgery and are left with scarring. Of these, over half a million patients undergo scar revision surgery. These types of scars are usually disfiguring, aesthetically unpleasant and can cause complications such as severe itching, tenderness, pain, depression and disruption of daily activities which can lead to a diminished quality of life. There is a clinical need for treatments that reduce scarring, as current therapies are often ineffective or inadequate.
Results from previous clinical trials show that Juvista is effective in improving scars in young and elderly males and females. Juvista-treated wounds appear to heal with scars that are more similar to the surrounding skin, and are narrower and paler with a faster fading of redness compared to placebo and standard care alone. This study will confirm the effectiveness of Juvista (avotermin) in the improvement of scar appearance when applied to the wound margins of patients following scar revision surgery of disfiguring scars.
The study is a double blind, within patient, placebo controlled, randomised trial in male and female patients. Patients will be asked to attend 10 study visits and will be followed up post-surgery for 12 months.
The potential benefits to the patients taking part in the trial will be that their scar is revised by a plastic surgeon. This procedure should leave subjects with a less noticeable scar. The existing scar will be surgically removed and the resulting wound will be divided into two segments of equal length. In most patients, one segment will receive treatment with Juvista administered by intradermal injection, the other with placebo. A few patients will receive treatment with Juvista to both segments of the wound.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: Julia Cook, BSc | +44 (0)161 2767100 ext 7167 | julia.cook@renovo.com |
Contact: Lydia Demetriou, BSc | +44 (0)161 2767100 ext 7163 | lydia.demetriou@renovo.com |
United Kingdom | |
Renovo Clinical Trials Unit, 48 Grafton Street | Recruiting |
Manchester, United Kingdom, M13 9XX | |
Contact: Matt Everton +44 (0)1612767100 ext 7709 matthew.everton@renovo.com | |
Principal Investigator: Karen So, MBBS, MRCS | |
Selly Oak Hospital | Not yet recruiting |
Birmingham, United Kingdom, B29 6JD | |
Principal Investigator: Naiem Moiemen, MB BCh, MSC, FRCS (Ed)(Plast) |
Principal Investigator: | D A McGrouther, FRCS, MD | University of Manchester |
Responsible Party: | Renovo ( Julia Cook (Clinical Trial Manager) ) |
Study ID Numbers: | RN1001-0091 |
Study First Received: | August 26, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00742443 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Italy: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Hungary: National Institute of Pharmacy; Spain: Spanish Agency of Medicines; Spain: Ethics Committee; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Ethics Committee |
Scar Revision |
Skin Diseases Cicatrix |