CicatrixPhase 2NCT00627536
Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions
A Phase 2 study testing Avotermin in people with Cicatrix, run by Renovo at 1 site in United Kingdom.
Trial summary
This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cicatrix
- What is being tested?
- Avotermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2006to Mar 2007
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 18-85 years who had given written informed consent.
- Subjects with a body mass index within 15 to 35 kg/m2.
- Subjects with clinically acceptable results for the laboratory tests
- Female subjects of child bearing potential who are using acceptable method(s) of contraception.
Who cannot join
- Subjects with history or evidence of hypertrophic or keloid scarring.
- Subjects with tattoos or previous scars within 3cm of the area to be incised.
- Subjects with prior surgery in the area to be incised within one year of the first dosing day.
- Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy.
- Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial.
- Subjects with a clinically significant skin disorder that is chronic or currently active.
Show all 16Show fewer
- Subjects with any clinically significant medical condition or history that would impair wound healing.
- Subjects with a history of drug hypersensitivity to any of the drugs or dressings used in this trial.
- Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
- Subjects who are taking regular, continuous, oral corticosteroid therapy.
- Subjects undergoing investigations or changes in management for an existing medical condition.
- Subjects with a history of drug abuse, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period.
- Subjects who are considered unlikely to complete the trial for whatever reason.
- Subjects with a clinically significant neurological impairment or disease.
- Subjects with any active infection.
- Subjects who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomised Dose-Ranging Trial to Investigate the Efficacy of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers
This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
- Conditions
- Cicatrix
- Being tested
- Avotermin, Placebo
- Keywords
- scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3
- Medical subject headings
- Cicatrix, Arrhythmogenic Right Ventricular Dysplasia, Familial, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvoterminDrug
Also called Juvista, RN1001, transforming growth factor beta 3
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
PlaceboDrug
Also called None applicable
Matched to avotermin dosage strength
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Avotermin 5ng/100μL/linear cm wound margin Receives: Drug: Avotermin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 3 | Experimental | Avotermin 50ng/100μL/linear cm wound margin Receives: Drug: Avotermin |
| 4 | Placebo comparator | Placebo matched to avotermin 50ng/100μL/linear cm Receives: Drug: Placebo |
| 5 | Experimental | Avotermin 200ng/100μL/linear cm Receives: Drug: Avotermin |
| 6 | Placebo comparator | Placebo matched to avotermin 200ng/100μL/linear cm Receives: Drug: Placebo |
| 7 | Experimental | Avotermin 500ng/100μL/linear cm wound margin Receives: Drug: Avotermin |
| 8 | Placebo comparator | Placebo matched to avotermin 500ng/100μL/linear cm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar appearance
Measured: 7 months
Secondary outcomes (1)
Safety: adverse events, local tolerability
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJul 2006
- Primary completionMar 2007
- Study completionMar 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Bush, MBChB, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627536
- Sponsor's protocol ID
- RN1001-0050
- Status last verified
- Mar 2008
- First submitted
- 22 Feb 2008
- Last updated
- 4 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomised Dose-Ranging Trial to Investigate the Efficacy of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00627536
- Acronym / sponsor ID
- RN1001-0050
- Conditions
- Cicatrix
- Keywords
- scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 3 Mar 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 study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AvoterminAvotermin 5ng/100μL/linear cm wound margin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
| 3 | Experimental | Drug: AvoterminAvotermin 50ng/100μL/linear cm wound margin |
| 4 | Placebo comparator | Drug: PlaceboPlacebo matched to avotermin 50ng/100μL/linear cm |
| 5 | Experimental | Drug: AvoterminAvotermin 200ng/100μL/linear cm |
| 6 | Placebo comparator | Drug: PlaceboPlacebo matched to avotermin 200ng/100μL/linear cm |
| 7 | Experimental | Drug: AvoterminAvotermin 500ng/100μL/linear cm wound margin |
| 8 | Placebo comparator | Drug: PlaceboPlacebo matched to avotermin 500ng/100μL/linear cm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 18-85 years who had given written informed consent.
- Subjects with a body mass index within 15 to 35 kg/m2.
- Subjects with clinically acceptable results for the laboratory tests
- Female subjects of child bearing potential who are using acceptable method(s) of contraception.
Key exclusion criteria (16 listed)
- Subjects with history or evidence of hypertrophic or keloid scarring.
- Subjects with tattoos or previous scars within 3cm of the area to be incised.
- Subjects with prior surgery in the area to be incised within one year of the first dosing day.
- Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy.
- Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial.
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 |
|---|---|---|
| AvoterminAlso: Juvista, RN1001, transforming growth factor beta 3A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure. | Drug | 1, 3, 5, 7 |
| PlaceboAlso: None applicableMatched to avotermin dosage strength | Drug | 2, 4, 6, 8 |
Primary outcome
Scar appearance
Time frame: 7 months
1 secondary outcome
Safety: adverse events, local tolerability
Time frame: 7 months
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 4 Mar 2008.
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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 Bush, MBChB 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 Phase 2 study testing Avotermin in people with Cicatrix, 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 4 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 4 Mar 2008. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Scar appearance (time frame: 7 months). 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 4 Mar 2008.