Juvista in Scar Revision Surgery of Disfiguring Scars

NCT ID: NCT00742443

Last Updated: 2011-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-02-28

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.

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.

Conditions

Cicatrix

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Active versus Placebo within patient

Group Type: OTHER

Juvista (avotermin)

Intervention Type: 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

2

Active vs. Placebo within patient

Group Type: OTHER

Juvista (avotermin)

Intervention Type: DRUG

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

3

Active vs. Active within patient

Group Type: OTHER

Juvista (avotermin)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

RN1001, TGFβ3; RN1001, TGFβ3; RN1001, TGFβ3

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Renovo

Principal Investigators

D A McGrouther, FRCS, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

BodyAesthetic Research Center

St Louis, Missouri, United States

Grymer Privathospital

Aarhus, , Denmark

Odense Universitetshopital

Odense, , Denmark

Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C

Viruni, , Denmark

Hôpital Henri Mondor

Créteil, , France

Hôpital maternité de Metz

Metz, , France

CHU Lapeyronie

Montpelliers, , France

Hôpital Emile Muller, Service de chirurgie plastique

Mulhouse, , France

Martin Luther Krankenhaus

Berlin, , Germany

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

Berlin, , Germany

BG-Universitätsklinik Bergmannsheil GmbH

Bochum, , Germany

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

Bochum, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

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

Jena, , Germany

Rotes-Kreuz-Krankenhaus Kassel

Kassel, , Germany

BG - Unfallklinik Ludwigshafen

Ludwigshafen Am Main, , Germany

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

Lübeck, , Germany

Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66

Offenbach, , Germany

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, , Germany

Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet

Budapest, , Hungary

HM Állami Egészségügyi Központ

Budapest, , Hungary

Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ

Budapest, , Hungary

Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.

Debrecen, , Hungary

Miskolci Egészségügyi Központ

Miskolc, , Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, , Hungary

Università degli studi di Genova

Genova, , Italy

Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

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

Pavia, , Italy

Chirurgia Plastica, Umberto I Policlinico di Roma

Rome, , Italy

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

Varese, , Italy

Paula Stradina Clinical University Hospital

Riga, , Latvia

110 Szpital Wojskowy z Przychodnia

Elblag, , Poland

Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne

Gdansk, , Poland

Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski

Gryfice, , Poland

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

Krakow, , Poland

Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,

Warsaw, , Poland

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Nuestra Señora del Perpetuo Socorro

Albacete, , Spain

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

Barcelona, , Spain

Hospital Clinic, Departament o Cirugia plástica

Barcelona, , Spain

Ibermutuamur

Madrid, , Spain

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

Santiago de Compostela, , Spain

Queen Victoria Hospital (QVH) NHS Foundation Trust

East Grinstead, West Sussex, United Kingdom

Selly Oak Hospital

Birmingham, , United Kingdom

Bristol Plastic Surgery

Bristol, , United Kingdom

Nuffield Health Bristol Hospital

Bristol, , United Kingdom

Renovo Clinical Trials Unit, 48 Grafton Street

Manchester, , United Kingdom

Countries

United States; Denmark; France; Germany; Hungary; Italy; Latvia; Poland; Spain; United Kingdom

Other Identifiers

RN1001-0091

Identifier Type: -

Identifier Source: org_study_id