ScarsNCT00821457
Juvista in the Non-surgical Improvement of Existing Scars
A study testing Juvista in people with Scars, run by Renovo at 1 site in United Kingdom.
Trial summary
Renovo, a Biopharmaceutical company involved in the development of drugs to improve the appearance of scars and enhance wound healing, are proposing to carry out research in improving the appearance of existing scars that are 2-6 months old using Juvista. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Scars
- What is being tested?
- Juvista
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Mar 2010
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Female Caucasian patients aged 18-45 years who have provided written informed consent.
- A body mass index between 15 and 35 kg/m2 (calculated using Quetelet's index [weight (kg)/height m2]
- Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Section 6.4.2). All laboratory tests must be performed within 28 days of the first trial dose administration.
- Female patients of child bearing potential who are 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. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner
- The scar to be treated is 2-6 months old at Day 0.
- The scar is linear.
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- The scar to be treated is symmetrical in appearance around the mid-line.
- The scar to be treated is between 7cm and 20cm in length and a maximum of 1cm in width.
- The scar to be treated runs along a flat surface which is in the same focal plane and suitable for accurate medical photography.
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 including :
- Significant rheumatoid arthritis.
- Significant hepatic impairment (LFTs >3 times upper limit of normal).
- Inadequately or uncontrolled congestive heart failure.
- Currently active malignancy or history of any malignancy in the 5 years prior to the screening visit.
- Immunosuppression or chemotherapy in the twelve months prior to the screening visit.
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- A history of radiotherapy to the study scar area.
- Diabetes mellitus (unless controlled by diet and exercise alone).
- A bleeding disorder or current use of anti-thrombotic therapy (aspirin, ticlopidine and clopidogrel are permitted).
- 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 :
- o 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 and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Patients with a history of clinically relevant allergy, hypersensitivity, angioedema, or anaphylaxis.
- Patients with a progressive neurological condition including Parkinson's disease, Alzheimer's disease and uncontrolled epilepsy.
- Patients with a known history of chronic viral infection (Hepatitis, HIV) or ongoing active infection.
- Patients with bleeding disorders including haemophilia, purpura or thrombocytopenia or receiving anticoagulants (e.g. warfarin, coumadin).
- Patients with an ongoing psychiatric condition requiring treatment or psychosis (including depression with psychosis, bipolar disease and schizophrenia.
- Patients with a history of clinically significant hypersensitivity to any of the drugs, surgical markers 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.
- Female patients who are breast feeding, or intending to become pregnant or breast feed during the study period (subjects must be using adequate contraception and have a negative pregnancy test at screening).
- Female patients who have had any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipate any change during study participation
- In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
- Patients with a history of substance abuse or dependency (a history of recreational use of cannabis is acceptable assuming a negative urine test for cannabis at screen. Patients who have had a history of alcohol abuse but have been dependency free for 12 months will still be eligible).
- Patients who on direct questioning and physical examination have a history or evidence of keloid scarring.
- Patients with additional scars less than 3cm away from the scar to be treated.
- The scar to be treated is a facial scar.
- Patients who are involved in ongoing litigation in connection with the scar to be treated.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Renovo Clinical Trial Unit
Manchester, Greater Manchester, WA5 8GG
About this study
Official title: A Within Patient, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy of Juvista in Improving the Appearance of Existing Scars That Are 2-6 Months Old
Renovo, a Biopharmaceutical company involved in the development of drugs to improve the appearance of scars and enhance wound healing, are proposing to carry out research in improving the appearance of existing scars that are 2-6 months old using Juvista. Juvista has not previously been administered to pre-existing scars without surgical revision, but it is thought that some beneficial effects seen with Juvista in previous trials may also be seen when administered to existing scars whilst the scar is maturing. This proof of concept study will therefore investigate the effect of Juvista in Caucasian male and female patients when administered to scars that are between two and six months old.
Scarring in the skin can vary hugely between individuals; therefore the most reliable way to assess the efficacy of an improvement of scar appearance is to use a model where each patient acts as their own control. A placebo will also be used for this trial as there are currently no approved pharmaceuticals for the improvement of scarring.
Read more
A total of 20 patients will be allocated to one of two dosing groups. Patients who enter the study will have linear scars resulting from broken skin (e.g. trauma, surgery) between 7 and 20cm in length, as well as meeting other specific criteria. The scar to be treated will be divided into two equal segments. Each segment will receive an intradermal injection of Juvista or placebo on Day 0 and 24 hours later.
The measure of change in scar appearance will be performed using colour analysis which will assess the change in colour between the Juvista treated segments versus the placebo treated segment of the scar, with reference to the surrounding skin within each patient.
- Conditions
- Scars
- Being tested
- Juvista, Placebo
- Keywords
- existing scars the are two to six months old
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvistaDrug
Also called Avotermin, Recombinant Transforming Growth Factor Beta 3
250ng
PlaceboDrug
Powder for solution for injection
JuvistaDrug
Also called Avotermin, Recombinant Transforming Growth Factor Beta 3
500ng
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 250ng Juvista vs placebo Receives: Drug: Juvista; Drug: Placebo |
| Group 2 | Active comparator | 500 ng Juvista vs placebo Receives: Drug: Placebo; Drug: Juvista |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the change in scar appearance at 6 months post treatment, assessed by calculating the colour difference between the treated scar sections with reference to the surrounding skin.
Measured: 6 months post treatment
Secondary outcomes (1)
The secondary efficacy variable is the difference in scar appearance between active and placebo treated segments at 6 months post treatment as assessed using a global scar comparison scale
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Dr Bush, MBChB MRCS, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821457
- Sponsor's protocol ID
- RN1001-0098
- Status last verified
- Mar 2010
- First submitted
- 12 Jan 2009
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Within Patient, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy of Juvista in Improving the Appearance of Existing Scars That Are 2-6 Months Old
- ClinicalTrials.gov ID
- NCT00821457
- Acronym / sponsor ID
- RN1001-0098
- Conditions
- Scars
- Keywords
- existing scars the are two to six months old
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 13 Jan 2009 (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.
Renovo, a Biopharmaceutical company involved in the development of drugs to improve the appearance of scars and enhance wound healing, are proposing to carry out research in improving the appearance of existing scars that are 2-6 months old using Juvista. Juvista has not previously been administered to pre-existing scars without surgical revision, but it is thought that some beneficial effects seen with Juvista in previous trials may also be seen when administered to existing scars whilst the scar is maturing. This proof of concept study will therefore investigate the effect of Juvista in Caucasian male and female patients when administered to scars that are between two and six months old.
Scarring in the skin can vary hugely between individuals; therefore the most reliable way to assess the efficacy of an improvement of scar appearance is to use a model where each patient acts as their own control. A placebo will also be used for this trial as there are currently no approved pharmaceuticals for the improvement of scarring.
A total of 20 patients will be allocated to one of two dosing groups. Patients who enter the study will have linear scars resulting from broken skin (e.g. trauma, surgery) between 7 and 20cm in length, as well as meeting other specific criteria. The scar to be treated will be divided into two equal segments. Each segment will receive an intradermal injection of Juvista or placebo on Day 0 and 24 hours later.
The measure of change in scar appearance will be performed using colour analysis which will assess the change in colour between the Juvista treated segments versus the placebo treated segment of the scar, with reference to the surrounding skin within each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Juvista, Drug: Placebo250ng Juvista vs placebo |
| Group 2 | Active comparator | Drug: Placebo, Drug: Juvista500 ng Juvista vs placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and Female Caucasian patients aged 18-45 years who have provided written informed consent.
- A body mass index between 15 and 35 kg/m2 (calculated using Quetelet's index [weight (kg)/height m2]
- Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Section 6.4.2). All laboratory tests must be performed within 28 days of the first trial dose administration.
- Female patients of child bearing potential who are 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. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner
- The scar to be treated is 2-6 months old at Day 0.
Key exclusion criteria (28 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 including :
- 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 :
- o 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 and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Patients with a history of clinically relevant allergy, hypersensitivity, angioedema, or anaphylaxis.
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 |
|---|---|---|
| JuvistaAlso: Avotermin, Recombinant Transforming Growth Factor Beta 3250ng | Drug | Group 1 |
| PlaceboPowder for solution for injection | Drug | Group 1, Group 2 |
| JuvistaAlso: Avotermin, Recombinant Transforming Growth Factor Beta 3500ng | Drug | Group 2 |
Primary outcome
The primary efficacy variable is the change in scar appearance at 6 months post treatment, assessed by calculating the colour difference between the treated scar sections with reference to the surrounding skin.
Time frame: 6 months post treatment
1 secondary outcome
The secondary efficacy variable is the difference in scar appearance between active and placebo treated segments at 6 months post treatment as assessed using a global scar comparison scale
Time frame: 6 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
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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.
James Dr Bush, MBChB MRCS principal investigator
Renovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juvista in people with Scars, run by Renovo at 1 site in United Kingdom.
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 9 inclusion and 28 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: withdrawn, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary efficacy variable is the change in scar appearance at 6 months post treatment, assessed by calculating the colour difference between the treated scar sections with reference to the surrounding skin. (time frame: 6 months post treatment). 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 9 Mar 2010.