Juvista in Scar Revision Surgery of Disfiguring Scars

Cicatrix Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742443
• Other study ID #: RN1001-0091
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2008
• Last updated: March 2, 2011
• Start date: December 2008
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeItaly: Ethics CommitteeItaly: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics CommitteeHungary: National Institute of PharmacyHungary: Institutional Ethics CommitteeSpain: Spanish Agency of MedicinesSpain: Ethics CommitteeGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionDenmark: Ethics CommitteeDenmark: Danish Medicines AgencyLatvia: State Agency of MedicinesLatvia: Institutional Review BoardUnited States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cicatrix

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Denmark	Grymer Privathospital	Aarhus
Denmark	Odense Universitetshopital	Odense
Denmark	Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C	Viruni
France	Hôpital Henri Mondor	Créteil
France	Hôpital maternité de Metz	Metz
France	CHU Lapeyronie	Montpelliers
France	Hôpital Emile Muller, Service de chirurgie plastique	Mulhouse
Germany	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
Germany	Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35	Jena
Germany	Rotes-Kreuz-Krankenhaus Kassel	Kassel
Germany	Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160	Lubeck
Germany	BG - Unfallklinik Ludwigshafen	Ludwigshafen am Main
Germany	Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66	Offenbach
Germany	Krankenhaus Barmherzige Brüder Regensburg	Regensburg
Hungary	Fovárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelointézet	Budapest
Hungary	HM Állami Egészségügyi Központ	Budapest
Hungary	Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ	Budapest
Hungary	Kenézy Kórház Rendelointézet Egészségügyi Szolgáltató Kft.	Debrecen
Hungary	Miskolci Egészségügyi Központ	Miskolc
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged
Italy	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
Latvia	Paula Stradina Clinical University Hospital	Riga
Poland	110 Szpital Wojskowy z Przychodnia	Elblag
Poland	Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne	Gdansk
Poland	Samodzielny Publiczny Zespól Zakladów Opieki Zdrowotnej Zachodniopomorski	Gryfice
Poland	Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Zlotej Jesieni 1	Krakow
Poland	Wojskowy Instytut Medyczny Kliniczny Oddzial Chirurgii Plastycznej,	Warsaw
Spain	Hospital Universitario Nuestra Señora del Perpetuo Socorro	Albacete
Spain	Hospital Clinic, Departament o Cirugia plástica	Barcelona
Spain	Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica	Barcelona
Spain	Ibermutuamur	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica	Santiago de Compostela
United Kingdom	Selly Oak Hospital	Birmingham
United Kingdom	Bristol Plastic Surgery	Bristol
United Kingdom	Nuffield Health Bristol Hospital	Bristol
United Kingdom	Queen Victoria Hospital (QVH) NHS Foundation Trust	East Grinstead	West Sussex
United Kingdom	Renovo Clinical Trials Unit, 48 Grafton Street	Manchester
United States	BodyAesthetic Research Center	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars.		12 months post surgery	No
Secondary	Global Scar Comparison Scale assessed by the patient looking at their own scars.		12 months post surgery	No