Juvista in Scar Revision Surgery of Disfiguring Scars

NCT00742443 | Completed Phase 3

• 1 other identifier: RN1001-0091
• Study Type: interventional
• Target: 350
• Locations: 10 countries
• Sites: 47

Brief Summary

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.

Conditions

Cicatrix

Keywords

Scar Revision

Outcome Measures

Primary Outcomes (1)

• Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars.

  12 months post surgery

Secondary Outcomes (1)

• Global Scar Comparison Scale assessed by the patient looking at their own scars.

  12 months post surgery

Study Arms (3)

1

OTHER

Active versus Placebo within patient

Drug: Juvista (avotermin)

2

OTHER

Active vs. Placebo within patient

Drug: Juvista (avotermin)

3

OTHER

Active vs. Active within patient

Drug: Juvista (avotermin)

Interventions

Juvista (avotermin) DRUG

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

Also known as: RN1001, TGFβ3

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renovo: lead

Study Sites (47)

BodyAesthetic Research Center

St Louis, Missouri, 63141, United States

Location

Grymer Privathospital

Aarhus, 8200, Denmark

Location

Odense Universitetshopital

Odense, Denmark

Location

Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C

Viruni, 2830, Denmark

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital maternité de Metz

Metz, 57045, France

Location

CHU Lapeyronie

Montpelliers, 34295, France

Location

Hôpital Emile Muller, Service de chirurgie plastique

Mulhouse, 68070, France

Location

Martin Luther Krankenhaus

Berlin, 14193, Germany

Location

Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Warener Strasse 7

Berlin, D-12683, Germany

Location

BG-Universitätsklinik Bergmannsheil GmbH

Bochum, D-44789, Germany

Location

St Josef und St Elisabeth Hospital, Klinik fur Dermatologie und Allergologie, Gundrunstrasse 56

Bochum, D-44791, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35

Jena, D-07740, Germany

Location

Rotes-Kreuz-Krankenhaus Kassel

Kassel, D-34121, Germany

Location

BG - Unfallklinik Ludwigshafen

Ludwigshafen Am Main, D-67071, Germany

Location

Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160

Lübeck, D-23538, Germany

Location

Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66

Offenbach, D-63069, Germany

Location

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, D-93049, Germany

Location

Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet

Budapest, 1097, Hungary

Location

HM Állami Egészségügyi Központ

Budapest, 1134, Hungary

Location

Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ

Budapest, 1146, Hungary

Location

Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.

Debrecen, 4043, Hungary

Location

Miskolci Egészségügyi Központ

Miskolc, 3529, Hungary

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, 6720, Hungary

Location

Università degli studi di Genova

Genova, 16132, Italy

Location

Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Fondazione S. Maugeri, U.O. DI CHIRURGIA PLASTICA E RICOSTRUTTIVA

Pavia, 27100, Italy

Location

Chirurgia Plastica, Umberto I Policlinico di Roma

Rome, 00161, Italy

Location

Ospedale di Circolo di Varese "Fondazione Macchi", Chirurgia Plastica

Varese, 21100, Italy

Location

Paula Stradina Clinical University Hospital

Riga, LV-1002, Latvia

Location

110 Szpital Wojskowy z Przychodnia

Elblag, 82307, Poland

Location

Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski

Gryfice, 72-300, Poland

Location

Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Złotej Jesieni 1

Krakow, 31-826, Poland

Location

Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,

Warsaw, 00909, Poland

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Nuestra Señora del Perpetuo Socorro

Albacete, 02006, Spain

Location

Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica

Barcelona, 08025, Spain

Location

Hospital Clinic, Departament o Cirugia plástica

Barcelona, 8036, Spain

Location

Ibermutuamur

Madrid, 28043, Spain

Location

Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica

Santiago de Compostela, 15706, Spain

Location

Queen Victoria Hospital (QVH) NHS Foundation Trust

East Grinstead, West Sussex, RH19 3DZ, United Kingdom

Location

Selly Oak Hospital

Birmingham, B29 6JD, United Kingdom

Location

Bristol Plastic Surgery

Bristol, BS1 4LF, United Kingdom

Location

Nuffield Health Bristol Hospital

Bristol, BS8 1JU, United Kingdom

Location

Renovo Clinical Trials Unit, 48 Grafton Street

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, human

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• D A McGrouther, FRCS, MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 3, 2011

Record last verified: 2011-03

Locations

GB (5); ES (6); US (1); DE (11); IT (5); HU (6); LA (1); FR (4); PL (5); DK (3)