Scar ImprovementPhase 1RN1006NCT01029158
A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo
A Phase 1 study testing Juvista (Avotermin) and RN1006 (Avotermin) in people with Scar Improvement, run by Renovo at 1 site in United Kingdom.
Trial summary
RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar Improvement
- What is being tested?
- Juvista (Avotermin) and RN1006 (Avotermin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Nov 2010
- Phase
- Phase 1
- 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 have given written informed consent
- Subjects with a body mass index within range 18-35 kg/m2
- Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol
- Female subjects using a highly effective method (S) of contraception
Who cannot join
- Subjects who have a history of keloid scarring, surgery within one year of the first dosing area
- Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised
- Subjects with any clinically significant medical condition or history of any condition which may impair wound healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects
RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model
- Conditions
- Scar Improvement
- Being tested
- Juvista (Avotermin), RN1006 (Avotermin), Placebo
- Keywords
- Healthy volunteers, Comparison of two formulations, Improvement of scar appearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvista (Avotermin)Drug
Also called juvista, RN1001
250 ng, twice, intradermal injection, standard formulation
RN1006 (Avotermin)Drug
Also called RN1006
250 ng, intradermal injection, twice
RN1006 (Avotermin)Drug
Also called RN1006
205 ng, Intradermal injection, once
RN1006 (Avotermin)Drug
Also called RN1006
500ng, intradermal injection, once
Juvista (Avotermin)Drug
Also called Juvista, RN1001
250 ng, intradermal injection, twice
Juvista (Avotermin)Drug
Also called Juvista, RN1001
500 ng, intradermal injection, once
Juvista (Avotermin)Drug
Also called Juvista, RN1001
500 ng, intradermal injection, once
RN1006 (Avotermin)Drug
Also called RN1006
500 ng, intradermal injection, twice
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1a | Experimental | 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Receives: Drug: Juvista (Avotermin); Drug: Placebo |
| 1b | Experimental | 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Receives: Drug: RN1006 (Avotermin); Drug: Placebo |
| 1c | Experimental | 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Receives: Drug: RN1006 (Avotermin); Drug: Placebo |
| 1d | Experimental | 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Receives: Drug: RN1006 (Avotermin); Drug: Placebo |
| 2a | Experimental | 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Receives: Drug: Juvista (Avotermin); Drug: Placebo |
| 2b | Experimental | 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Receives: Drug: Juvista (Avotermin); Drug: Placebo |
| 2c | Experimental | 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Receives: Drug: Juvista (Avotermin); Drug: Placebo |
| 2d | Experimental | 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total). Receives: Drug: RN1006 (Avotermin); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global scar comparison scale
Measured: 12 months
Secondary outcomes (1)
Adverse event incidence including specific assessment of local tolerability at the treated wound site
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar ImprovementStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029158
- Sponsor's protocol ID
- RN1006-0100
- Acronym
- RN1006
- Status last verified
- Dec 2010
- First submitted
- 4 Dec 2009
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects
- ClinicalTrials.gov ID
- NCT01029158
- Acronym / sponsor ID
- RN1006 / RN1006-0100
- Conditions
- Scar Improvement
- Keywords
- Healthy volunteers, Comparison of two formulations, Improvement of scar appearance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Dec 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.
RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1a | Experimental | Drug: Juvista (Avotermin), Drug: Placebo250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
| 1b | Experimental | Drug: RN1006 (Avotermin), Drug: Placebo250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
| 1c | Experimental | Drug: RN1006 (Avotermin), Drug: Placebo250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. |
| 1d | Experimental | Drug: RN1006 (Avotermin), Drug: Placebo500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. |
| 2a | Experimental | Drug: Juvista (Avotermin), Drug: Placebo250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
| 2b | Experimental | Drug: Juvista (Avotermin), Drug: Placebo500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. |
| 2c | Experimental | Drug: Juvista (Avotermin), Drug: Placebo500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
| 2d | Experimental | Drug: RN1006 (Avotermin), Drug: Placebo500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total). |
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 have given written informed consent
- Subjects with a body mass index within range 18-35 kg/m2
- Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol
- Female subjects using a highly effective method (S) of contraception
Key exclusion criteria (3 listed)
- Subjects who have a history of keloid scarring, surgery within one year of the first dosing area
- Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised
- Subjects with any clinically significant medical condition or history of any condition which may impair wound healing
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: juvista, RN1001250 ng, twice, intradermal injection, standard formulation | Drug | 1a |
| RN1006 (Avotermin)Also: RN1006250 ng, intradermal injection, twice | Drug | 1b |
| RN1006 (Avotermin)Also: RN1006205 ng, Intradermal injection, once | Drug | 1c |
| RN1006 (Avotermin)Also: RN1006500ng, intradermal injection, once | Drug | 1d |
| Juvista (Avotermin)Also: Juvista, RN1001250 ng, intradermal injection, twice | Drug | 2a |
| Juvista (Avotermin)Also: Juvista, RN1001500 ng, intradermal injection, once | Drug | 2b |
| Juvista (Avotermin)Also: Juvista, RN1001500 ng, intradermal injection, once | Drug | 2c |
| RN1006 (Avotermin)Also: RN1006500 ng, intradermal injection, twice | Drug | 2d |
| PlaceboPlacebo | Drug | 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d |
Primary outcome
Global scar comparison scale
Time frame: 12 months
1 secondary outcome
Adverse event incidence including specific assessment of local tolerability at the treated wound site
Time frame: 12 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 9 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Juvista (Avotermin) and RN1006 (Avotermin) in people with Scar Improvement, 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 3 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 9 Dec 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (time frame: 12 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 9 Dec 2010.