Clinical trial NCT00742443: Juvista in Scar Revision Surgery of Disfiguring Scars
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cicatrix
Keywords: Scar Revision
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars.
timeFrame: 12 months post surgery
Secondary outcomes:
measure: Global Scar Comparison Scale assessed by the patient looking at their own scars.
timeFrame: 12 months post surgery
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: BodyAesthetic Research Center
state: Missouri
city: Aarhus
country: Denmark
facility: Grymer Privathospital
city: Odense
country: Denmark
facility: Odense Universitetshopital
city: Viruni
country: Denmark
facility: Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Metz
country: France
facility: Hôpital maternité de Metz
city: Montpelliers
country: France
facility: CHU Lapeyronie
city: Mulhouse
country: France
facility: Hôpital Emile Muller, Service de chirurgie plastique
city: Berlin
country: Germany
facility: Martin Luther Krankenhaus
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Warener Strasse 7
city: Bochum
country: Germany
facility: BG-Universitätsklinik Bergmannsheil GmbH
city: Bochum
country: Germany
facility: St Josef und St Elisabeth Hospital, Klinik fur Dermatologie und Allergologie, Gundrunstrasse 56
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Jena
country: Germany
facility: Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35
city: Kassel
country: Germany
facility: Rotes-Kreuz-Krankenhaus Kassel
city: Lubeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160
city: Ludwigshafen am Main
country: Germany
facility: BG - Unfallklinik Ludwigshafen
city: Offenbach
country: Germany
facility: Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet
city: Budapest
country: Hungary
facility: HM Állami Egészségügyi Központ
city: Budapest
country: Hungary
facility: Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ
city: Debrecen
country: Hungary
facility: Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.
city: Miskolc
country: Hungary
facility: Miskolci Egészségügyi Központ
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
city: Genova
country: Italy
facility: Università degli studi di Genova
city: Palermo
country: Italy
facility: Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
city: Pavia
country: Italy
facility: Fondazione S. Maugeri, U.O. DI CHIRURGIA PLASTICA E RICOSTRUTTIVA
city: Rome
country: Italy
facility: Chirurgia Plastica, Umberto I Policlinico di Roma
city: Varese
country: Italy
facility: Ospedale di Circolo di Varese "Fondazione Macchi", Chirurgia Plastica
city: Riga
country: Latvia
facility: Paula Stradina Clinical University Hospital
city: Elblag
country: Poland
facility: 110 Szpital Wojskowy z Przychodnia
city: Gdansk
country: Poland
facility: Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne
city: Gryfice
country: Poland
facility: Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski
city: Krakow
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Złotej Jesieni 1
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Albacete
country: Spain
facility: Hospital Universitario Nuestra Señora del Perpetuo Socorro
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica
city: Barcelona
country: Spain
facility: Hospital Clinic, Departament o Cirugia plástica
city: Madrid
country: Spain
facility: Ibermutuamur
city: Santiago de Compostela
country: Spain
facility: Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital (QVH) NHS Foundation Trust
state: West Sussex
city: Birmingham
country: United Kingdom
facility: Selly Oak Hospital
city: Bristol
country: United Kingdom
facility: Bristol Plastic Surgery
city: Bristol
country: United Kingdom
facility: Nuffield Health Bristol Hospital
city: Manchester
country: United Kingdom
facility: Renovo Clinical Trials Unit, 48 Grafton Street
Study officials:
affiliation: University of Manchester
name: D A McGrouther, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
References: