Juvista in Scar Revision Surgery of Disfiguring Scars (Revise)

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00742443
First received: August 26, 2008
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double Blind, Within Patient, Placebo Controlled Trial to Assess the Efficacy of Juvista (Avotermin) in Conjunction With Scar Revision Surgery for the Improvement of Disfiguring Scars.

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars. [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Scar Comparison Scale assessed by the patient looking at their own scars. [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: December 2008
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Active versus Placebo within patient
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
Other Name: RN1001, TGFβ3
2
Active vs. Placebo within patient
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
Other Name: RN1001, TGFβ3
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
Other Name: RN1001, TGFβ3

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-85 years who have provided written informed consent.
  • BMI between 15 and 35 kg/m2
  • Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
  • If females of child bearing potential, patients must be using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose.
  • The scar area to be revised is disfiguring. To be considered disfiguring for this trial scars must have at least one of the following characteristics.
  • Scar area 13 or more cm in length.
  • Scar area at least 0.6 cm wide at widest part.
  • Surface contour of scar area elevated or depressed on palpation.
  • Scar area adherent to underlying tissue.
  • Skin hypo-or hyper-pigmented in an area exceeding 39cm2.
  • Skin texture abnormal (irregular, atrophic, shiny, scaly, etc.) in an area exceeding 39cm2.
  • The scar to be revised is at least 12 months old.
  • The investigator considers that the appearance of the scar area to be revised can be improved with surgery alone.
  • The scar area is linear and suitable for revision by excision and direct closure.
  • The scar area to be revised is symmetrical in appearance around the mid-line.
  • The scar area to be revised is between 7 and 20cm in length.
  • The scar area to be revised runs along a flat surface which is in the same focal plane and suitable for accurate medical photography.
  • The scar is approved for entry into the trial by the Independent Expert Screening Panel.

Exclusion Criteria

  • Patients who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
  • Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula :
  • CLcr = (140-age (years)) x weight(kg)/ 72 x serum creatinine (mg/dL) {x 0.85 for females}
  • Patients with a skin disorder that is chronic or currently active.
  • Patients who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits.
  • Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
  • Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
  • Patients undergoing investigations or changes in management for an existing medical condition (excluding the scar for revision).
  • Patients who are or who become pregnant up to and including Day 0 or who are lactating.
  • In the opinion of the Investigator, a patient who is not likely to complete the trial.
  • Patients who on direct questioning and physical examination have history or evidence of keloid scarring.
  • Patients with scar areas for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar or difficulty in taking photographs.
  • Patients with additional scars less than 3cm away from the area to be revised.
  • Patients with scars that require revision using Z-plasty, W-plasty or any other such techniques.
  • Patients who are involved in ongoing litigation in connection with the scar to be revised.
  • Patients who have had surgery in the area to be excised within one year of Day 0.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742443

  Hide Study Locations
Locations
United States, Missouri
BodyAesthetic Research Center
St. Louis, Missouri, United States, 63141
Denmark
Grymer Privathospital
Aarhus, Denmark, 8200
Odense Universitetshopital
Odense, Denmark
Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C
Viruni, Denmark, 2830
France
Hôpital Henri Mondor
Créteil, France, 94010
Hôpital maternité de Metz
Metz, France, 57045
CHU Lapeyronie
Montpelliers, France, 34295
Hôpital Emile Muller, Service de chirurgie plastique
Mulhouse, France, 68070
Germany
Martin Luther Krankenhaus
Berlin, Germany, 14193
Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Warener Strasse 7
Berlin, Germany, D-12683
BG-Universitätsklinik Bergmannsheil GmbH
Bochum, Germany, D-44789
St Josef und St Elisabeth Hospital, Klinik fur Dermatologie und Allergologie, Gundrunstrasse 56
Bochum, Germany, D-44791
Universitätsklinikum Freiburg
Freiburg, Germany, D-79106
Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35
Jena, Germany, D-07740
Rotes-Kreuz-Krankenhaus Kassel
Kassel, Germany, D-34121
Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160
Lubeck, Germany, D-23538
BG - Unfallklinik Ludwigshafen
Ludwigshafen am Main, Germany, D-67071
Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66
Offenbach, Germany, D-63069
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany, D-93049
Hungary
Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet
Budapest, Hungary, 1097
Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ
Budapest, Hungary, 1146
HM Állami Egészségügyi Központ
Budapest, Hungary, 1134
Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.
Debrecen, Hungary, 4043
Miskolci Egészségügyi Központ
Miskolc, Hungary, 3529
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary, 6720
Italy
Università degli studi di Genova
Genova, Italy, 16132
Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Fondazione S. Maugeri, U.O. DI CHIRURGIA PLASTICA E RICOSTRUTTIVA
Pavia, Italy, 27100
Chirurgia Plastica, Umberto I Policlinico di Roma
Rome, Italy, 00161
Ospedale di Circolo di Varese "Fondazione Macchi", Chirurgia Plastica
Varese, Italy, 21100
Latvia
Paula Stradina Clinical University Hospital
Riga, Latvia, LV-1002
Poland
110 Szpital Wojskowy z Przychodnia
Elblag, Poland, 82307
Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne
Gdansk, Poland, 80-952
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski
Gryfice, Poland, 72-300
Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Złotej Jesieni 1
Krakow, Poland, 31-826
Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,
Warsaw, Poland, 00909
Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Universitario Nuestra Señora del Perpetuo Socorro
Albacete, Spain, 02006
Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica
Barcelona, Spain, 08025
Hospital Clinic, Departament o Cirugia plástica
Barcelona, Spain, 8036
Ibermutuamur
Madrid, Spain, 28043
Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica
Santiago de Compostela, Spain, 15706
United Kingdom
Queen Victoria Hospital (QVH) NHS Foundation Trust
East Grinstead, West Sussex, United Kingdom, RH19 3DZ
Selly Oak Hospital
Birmingham, United Kingdom, B29 6JD
Nuffield Health Bristol Hospital
Bristol, United Kingdom, BS8 1JU
Bristol Plastic Surgery
Bristol, United Kingdom, BS1 4LF
Renovo Clinical Trials Unit, 48 Grafton Street
Manchester, United Kingdom, M13 9XX
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: D A McGrouther, FRCS, MD University of Manchester
  More Information

No publications provided

Responsible Party: Julia Cook (Clinical Trial Manager), Renovo
ClinicalTrials.gov Identifier: NCT00742443     History of Changes
Other Study ID Numbers: RN1001-0091
Study First Received: August 26, 2008
Last Updated: March 2, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Italy: Ethics Committee
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Hungary: National Institute of Pharmacy
Hungary: Institutional Ethics Committee
Spain: Spanish Agency of Medicines
Spain: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Latvia: State Agency of Medicines
Latvia: Institutional Review Board
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Renovo:
Scar Revision

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014