CicatrixPhase 1/2NCT00847925
Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects
A Phase 1/2 study testing Avotermin (RN1001) in people with Cicatrix, run by Renovo at 1 site in United Kingdom.
Trial summary
A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects 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
- What is being tested?
- Avotermin (RN1001)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2001to Sep 2003
- Phase
- Phase 1/2
- 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
- Healthy, non-Afro-Caribbean, male subjects aged 18-45 years inclusive.
- Weight between 60 and 150kg and a body mass index between 15 - 55 kg/m2.
- Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation
Who cannot join
- Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring.
- Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
- Subjects with tattoos or previous scars in the areas to be biopsied.
- Subjects, who on direct questioning and physical examination, have evidence of any past or present clinically significant disease and particularly coagulation disorders, immuno mediated conditions and skin diseases and allergies, such as eczema.
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study.
- Subjects with any clinically significant abnormality following review of pre study laboratory data and full physical examination.
Show all 13Show fewer
- Subjects who are taking, or have taken, certain prescribed or investigational drug in the three weeks prior to Day 0 and in particular topical or systemic steroids, and anti-coagulant drugs. Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements, inhaled salbutamol, thyroxine replacement therapy, OTC cold remedies.
- Subjects who drink more than 28 units of alcohol per week (1 unit = ½ pint of beer (285mls) or 25ml of spirits or 1 glass of wine).
- Subjects who have current evidence of drug abuse.
- Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.
- Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.
- Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group.
- In the opinion of the investigator, a subject who is not likely to complete the study for what ever reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo and Standard Care Controlled, Randomised Study to Investigate the Clinical Safety and Toleration, Wound Healing and Antiscarring Potential of Two Applications of Intradermal RN1001 (Avotermin) in Healthy Male Subjects
A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects
Read the detailed description
Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject served as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing and subsequent scarring. Subjects were initially dosed and wounded (incisions and punch biopsies) on Day 0 and re-dosed on Day 1. On Day 3, Arm 1 incisions and punch biopsies were re-dosed as per Day 0 and excised, and re-dosed again on Day 4. Arm 2 punch biopsies were excised at Day 5 but not re-dosed. Healed incisions/scars on Arm 2 were excised for histological analysis after 12 months and not re-dosed. All subjects, regardless of treatment were treated according to best practices for moist wound healing.
- Conditions
- Cicatrix
- Being tested
- Avotermin (RN1001)
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avotermin (RN1001)Drug
100ul/linear cm of wound. Dosed before surgery and 24h later
| Study group | Role | What they receive |
|---|---|---|
| A | Other | 50ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| B | Other | 20ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| C | Other | 5ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| D | Other | 100ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| E | Other | 500ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| F | Other | 0.25ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| G | Other | 1ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| H | Other | 20ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
| I | Other | 50ng Avotermin/100ul Receives: Drug: Avotermin (RN1001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar severity
Measured: 12 Months
Secondary outcomes (1)
Treatment local and systemic tolerance
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 posted19 Feb 2009 (estimated)
- Study startNov 2001
- Primary completionSep 2003
- Study completionSep 2003
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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathan Duncan, MB BCh, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847925
- Sponsor's protocol ID
- RN1001-309-1002
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.
PubMed 19362676
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo and Standard Care Controlled, Randomised Study to Investigate the Clinical Safety and Toleration, Wound Healing and Antiscarring Potential of Two Applications of Intradermal RN1001 (Avotermin) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00847925
- Acronym / sponsor ID
- RN1001-309-1002
- Conditions
- Cicatrix
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 19 Feb 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.
A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects
Detailed description
Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject served as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing and subsequent scarring. Subjects were initially dosed and wounded (incisions and punch biopsies) on Day 0 and re-dosed on Day 1. On Day 3, Arm 1 incisions and punch biopsies were re-dosed as per Day 0 and excised, and re-dosed again on Day 4. Arm 2 punch biopsies were excised at Day 5 but not re-dosed. Healed incisions/scars on Arm 2 were excised for histological analysis after 12 months and not re-dosed. All subjects, regardless of treatment were treated according to best practices for moist wound healing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Avotermin (RN1001)50ng Avotermin/100ul |
| B | Other | Drug: Avotermin (RN1001)20ng Avotermin/100ul |
| C | Other | Drug: Avotermin (RN1001)5ng Avotermin/100ul |
| D | Other | Drug: Avotermin (RN1001)100ng Avotermin/100ul |
| E | Other | Drug: Avotermin (RN1001)500ng Avotermin/100ul |
| F | Other | Drug: Avotermin (RN1001)0.25ng Avotermin/100ul |
| G | Other | Drug: Avotermin (RN1001)1ng Avotermin/100ul |
| H | Other | Drug: Avotermin (RN1001)20ng Avotermin/100ul |
| I | Other | Drug: Avotermin (RN1001)50ng Avotermin/100ul |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, non-Afro-Caribbean, male subjects aged 18-45 years inclusive.
- Weight between 60 and 150kg and a body mass index between 15 - 55 kg/m2.
- Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation
Key exclusion criteria (13 listed)
- Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring.
- Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
- Subjects with tattoos or previous scars in the areas to be biopsied.
- Subjects, who on direct questioning and physical examination, have evidence of any past or present clinically significant disease and particularly coagulation disorders, immuno mediated conditions and skin diseases and allergies, such as eczema.
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study.
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 |
|---|---|---|
| Avotermin (RN1001)100ul/linear cm of wound. Dosed before surgery and 24h later | Drug | A, B, C, D, E, F, G, H, I |
Primary outcome
Scar severity
Time frame: 12 Months
1 secondary outcome
Treatment local and systemic tolerance
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 19 Feb 2009.
- Derived from this study: PubMed 19362676Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.
Related trials for Cicatrix
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
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.
Jonathan Duncan, MB BCh 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 1/2 study testing Avotermin (RN1001) 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 3 inclusion and 13 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 19 Feb 2009. 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 combined 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.
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 severity (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 NCT00847925, 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 19 Feb 2009.