CicatrixPhase 3ReviseNCT00742443
Juvista in Scar Revision Surgery of Disfiguring Scars
A Phase 3 study testing Juvista (avotermin) in people with Cicatrix, run by Renovo at 47 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cicatrix
- What is being tested?
- Juvista (avotermin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 47 sitesin 10 countries
- Study dates
- Dec 2008to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
47 sites in 10 countries.
47 sites in 10 countries
Germany11 sites
Martin Luther Krankenhaus
Berlin, 14193
Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Warener Strasse 7
Berlin, D-12683
BG-Universitätsklinik Bergmannsheil GmbH
Bochum, D-44789
St Josef und St Elisabeth Hospital, Klinik fur Dermatologie und Allergologie, Gundrunstrasse 56
Bochum, D-44791
Universitätsklinikum Freiburg
Freiburg im Breisgau, D-79106
Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35
Jena, D-07740
Rotes-Kreuz-Krankenhaus Kassel
Kassel, D-34121
Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160
Lübeck, D-23538
BG - Unfallklinik Ludwigshafen
Ludwigshafen Am Main, D-67071
Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66
Offenbach, D-63069
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, D-93049
Hungary6 sites
Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet
Budapest, 1097
HM Állami Egészségügyi Központ
Budapest, 1134
Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ
Budapest, 1146
Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.
Debrecen, 4043
Miskolci Egészségügyi Központ
Miskolc, 3529
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6720
Spain6 sites
Hospital Universitario Nuestra Señora del Perpetuo Socorro
Albacete, 02006
Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica
Barcelona, 08025
Hospital Clinic, Departament o Cirugia plástica
Barcelona, 8036
Ibermutuamur
Madrid, 28043
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica
Santiago de Compostela, 15706
Italy5 sites
Università degli studi di Genova
Genova, 16132
Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Fondazione S. Maugeri, U.O. DI CHIRURGIA PLASTICA E RICOSTRUTTIVA
Pavia, 27100
Chirurgia Plastica, Umberto I Policlinico di Roma
Rome, 00161
Ospedale di Circolo di Varese "Fondazione Macchi", Chirurgia Plastica
Varese, 21100
Poland5 sites
110 Szpital Wojskowy z Przychodnia
Elblag, 82307
Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne
Gdansk, 80-952
Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski
Gryfice, 72-300
Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Złotej Jesieni 1
Krakow, 31-826
Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,
Warsaw, 00909
United Kingdom5 sites
Selly Oak Hospital
Birmingham, B29 6JD
Bristol Plastic Surgery
Bristol, BS1 4LF
Nuffield Health Bristol Hospital
Bristol, BS8 1JU
Queen Victoria Hospital (QVH) NHS Foundation Trust
East Grinstead, West Sussex, RH19 3DZ
Renovo Clinical Trials Unit, 48 Grafton Street
Manchester, M13 9XX
France4 sites
Hôpital Henri Mondor
Créteil, 94010
Hôpital maternité de Metz
Metz, 57045
CHU Lapeyronie
Montpelliers, 34295
Hôpital Emile Muller, Service de chirurgie plastique
Mulhouse, 68070
Denmark3 sites
Grymer Privathospital
Aarhus, 8200
Odense Universitetshopital
Odense
Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C
Viruni, 2830
United States1 site
BodyAesthetic Research Center
St Louis, Missouri, 63141
About this study
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.
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.
Read the 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
- Being tested
- Juvista (avotermin)
- Keywords
- Scar Revision
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvista (avotermin)Drug
Also called RN1001, TGFβ3
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)Drug
Also called RN1001, TGFβ3
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)Drug
Also called RN1001, TGFβ3
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Active versus Placebo within patient Receives: Drug: Juvista (avotermin) |
| 2 | Other | Active vs. Placebo within patient Receives: Drug: Juvista (avotermin) |
| 3 | Other | Active vs. Active within patient Receives: Drug: Juvista (avotermin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars.
Measured: 12 months post surgery
Secondary outcomes (1)
Global Scar Comparison Scale assessed by the patient looking at their own scars.
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- D A McGrouther, FRCS, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742443
- Sponsor's protocol ID
- RN1001-0091
- Acronym
- Revise
- Status last verified
- Mar 2011
- First submitted
- 26 Aug 2008
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00742443
- Acronym / sponsor ID
- Revise / RN1001-0091
- Conditions
- Cicatrix
- Keywords
- Scar Revision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Juvista (avotermin)Active versus Placebo within patient |
| 2 | Other | Drug: Juvista (avotermin)Active vs. Placebo within patient |
| 3 | Other | Drug: Juvista (avotermin)Active vs. Active within patient |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juvista (avotermin)Also: RN1001, TGFβ3100ng/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 | Drug | 1 |
| Juvista (avotermin)Also: RN1001, TGFβ3250ng/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 | Drug | 2 |
| Juvista (avotermin)Also: RN1001, TGFβ3250ng/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 | Drug | 3 |
Primary outcome
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
1 secondary outcome
Global Scar Comparison Scale assessed by the patient looking at their own scars.
Time frame: 12 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D A McGrouther, FRCS, MD principal investigator
University of Manchester
47 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Juvista (avotermin) in people with Cicatrix, run by Renovo at 47 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany, Hungary, Spain, Italy, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2011.