CicatrixPhase 2NCT00594581
Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males
A Phase 2 study of Cicatrix, run by Renovo at 1 site in United Kingdom.
Trial summary
This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Mar 2005
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically healthy, male subjects aged 18 to 45 years (inclusive)
- Body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using Quetelet's index
Who cannot join
- Subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied.
- Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial.
- Afro-Caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring.
- Subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease.
- Subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial.
- Subjects with a history of clinically significant allergies.
Show all 17Show fewer
- Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination.
- Subjects taking, or who had taken, certain prescribed drugs in the 4 weeks before to Day 0 and, in particular, topical or systemic steroids, anti-inflammatory, anti-coagulant, anti-proliferative drugs, and antibiotics.
- Subjects who have taken part in a clinical trial within 3 months before admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not.
- Subjects with any clinical evidence of severe ongoing, or prolonged, depression or mental illness.
- Subjects smoking more than 20 cigarettes a day.
- Subjects drinking more than 28 units of alcohol per week (1 unit = ½ pint of beer [285ml], 25ml of spirits, or 1 glass of wine).
- Subjects showing evidence of drug abuse.
- Subjects known to have, or to have had, serum hepatitis or who were carriers of the hepatitis B surface antigen (HbsAg) or hepatitis C antibody.
- Subjects previously testing positive for HIV antibodies, or who admit to belonging to a high-risk group.
- Subjects with pre-existing clinically significant neurological conditions.
- Subjects who, in the opinion of an investigator, are not likely to complete the trial for whatever reason.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Trials Unit, Renovo Ltd
Manchester, La, M13 9XX
About this study
Official title: A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal Juvista (Avotermin) in Male Subjects Aged 18-45 Years
This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.
- Conditions
- Cicatrix
- Being tested
- Juvista (avotermin) plus placebo, standard-care (within-subject controls)
- Keywords
- cicatrix, scarring, TGF-beta3, avotermin, Juvista
- 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.
Juvista (avotermin) plus placebo, standard-care (within-subject controls)Drug
Also called Juvista, RN1001, Avotermin
Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Juvista (avotermin) 50ng/100μl/linear cm wound margin Receives: Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls) |
| 2 | Active comparator | Juvista (avotermin) at 200ng/100μl/linear cm Receives: Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar appearance
Measured: 12 months
Secondary outcomes (1)
Safety: adverse events, local tolerability, systemic exposure
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 posted15 Jan 2008 (estimated)
- Study startOct 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim Bush, MBChB, Principal investigator, Renovo Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594581
- Sponsor's protocol ID
- RN1001-319-1011
- Status last verified
- Jan 2008
- First submitted
- 11 Dec 2007
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.
PubMed 21042116
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal Juvista (Avotermin) in Male Subjects Aged 18-45 Years
- ClinicalTrials.gov ID
- NCT00594581
- Acronym / sponsor ID
- RN1001-319-1011
- Conditions
- Cicatrix
- Keywords
- cicatrix, scarring, TGF-beta3, avotermin, Juvista
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 15 Jan 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 safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)Juvista (avotermin) 50ng/100μl/linear cm wound margin |
| 2 | Active comparator | Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)Juvista (avotermin) at 200ng/100μl/linear cm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically healthy, male subjects aged 18 to 45 years (inclusive)
- Body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using Quetelet's index
Key exclusion criteria (17 listed)
- Subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied.
- Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial.
- Afro-Caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring.
- Subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease.
- Subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this 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 |
|---|---|---|
| Juvista (avotermin) plus placebo, standard-care (within-subject controls)Also: Juvista, RN1001, AvoterminIntradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin | Drug | 1, 2 |
Primary outcome
Scar appearance
Time frame: 12 months
1 secondary outcome
Safety: adverse events, local tolerability, systemic exposure
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 15 Jan 2008.
- Derived from this study: PubMed 21042116Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.
Related trials for Cicatrix
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingPhase 2
SCARFREE-001: Verteporfin for Scar Prevention
Surgical Scar
Enrolling by invitation
Nanofat Injection and Fractional CO2 Laser for Post-Traumatic Atrophic Scars
Post-Traumatic Atrophic Scar, Atrophic Scar
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
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.
Jim Bush, MBChB principal investigator
Renovo Ltd
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 of 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 2 inclusion and 17 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 15 Jan 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. 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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594581, which also lists 1 linked publication.
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 15 Jan 2008; AzTrials last refreshed its copy on 8 Nov 2026.