CicatrixPhase 2NCT00984503
Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites
A Phase 2 study testing Avotermin in people with Cicatrix and Wound Healing, run by Renovo at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the accelerated-healing potential of injection or injection plus topical application of Juvista to minor split skin grafts (SSG). Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Wound Healing
- 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
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Jan 2006
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically healthy, male subjects aged 18-85 years
- Weight between 40 and 150kg or a BMI within the permitted range for their height using Quetelet's index, 15-55 kg/m2. Weight (kg)/height (m)2.
Who cannot join
- Subjects who had a history or evidence of hypertrophic or keloid scarring or had tattoos or previous scars in the area of the prospective SSG donor sites
- Subjects who had received surgery to the area of the lower back/buttocks in the previous 12 months
- Afro-Caribbean subjects were excluded because of their increased susceptibility to hypertrophic and keloid scarring
- Subjects who had evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, immunomediated conditions, skin diseases and allergies (such as clinically significant eczema
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine, allergy to surgical dressings used in this trial or to any excipients or vehicle in the formulation or delivery vehicle
- Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination
Show all 16Show fewer
- Subjects who were receiving or had received certain prescribed drugs in the 4 weeks prior to Day 0, particularly topical or systemic steroids, anti- inflammatory, anti-coagulants, antiproliferative drugs and antibiotics. Certain drugs not excluded in this trial included over-the-counter analgesics, including paracetamol and codeine, vitamin and mineral supplements, and cold remedies. If antibiotics were required after Day 0 (e.g., for cases of wound infection), this did not result in the exclusion of affected subjects from the study
- Subjects who had taken part in a clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not.
- Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness
- Subjects who smoked more than 20 cigarettes a day
- Subjects who drank more than 28 units of alcohol per week (1 unit = ½ pint of beer [285ml], 25ml of spirits or 1 glass of wine)
- Subjects who demonstrated evidence of drug abuse
- Subjects who were known to have or have had serum hepatitis and those who are carriers of the hepatitis B surface antigen or hepatitis C antibody (Subjects with previous vaccination against hepatitis B were not excluded per se)
- Subjects who were known to have, or have had, serum hepatitis and those who were carriers of the hepatitis B core antibody with less than 10 units per litre of anti-hepatitis B (unless deemed NOT to be a carrier of hepatitis B after testing by the Public Health Laboratory)
- Subjects who had previously tested positive for HIV antibodies or who admitted to belonging to a high-risk group
- A subject who, in the opinion of the Investigator, was unlikely to complete the trial for whatever reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-site, Randomised, Double-blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure, Accelerated Healing and Anti-scarring Potential of Juvista in Split Skin Graft Donor Sites in Male Subjects Aged 18-85 Years
The purpose of this study is to investigate the accelerated-healing potential of injection or injection plus topical application of Juvista to minor split skin grafts (SSG).
Read the detailed description
Subjects were allocated into three groups (Group 1, Group 2 and Group 3) with all subjects receiving two 3cm2 SSG donor sites, one to each side of the lower back. Before wounding on Day 0, each site was randomised to receive either an intradermal injection of Juvista (50ng/100μl/cm2), an intradermal injection of Placebo (100μl/cm2) or no injection (Standard Care). After wounding, subjects allocated to Group 2 and Group 3 also received topical Juvista (100ng/200μl/cm2), topical Placebo (200μl/cm2) or Standard Care (Tegaderm dressing only). Topical Juvista and Placebo were held within a Granuflex ring dressing and sealed with a sterile Tegaderm dressing.
On Day 1, subjects in Group 2 and Group 3 received a further topical application of Juvista, Placebo or Standard Care according to the same treatment randomisation as Day 0.
Punch biopsy samples of healing SSG donor sites were harvested from Group 3 subjects on Day 3, 5, 7 or 10, and preserved for histological analysis.
The final study visit for Group 3 subjects was the day of the biopsy visit. Subjects in Group 1 and Group 2 underwent scar assessments at the first follow-up at Month 1 and at Months 2, 3, 4, 5, 6, 9 and 12.
- Conditions
- Cicatrix, Wound Healing
- Being tested
- Avotermin, Placebo
- Keywords
- Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvoterminDrug
Also called Juvista, TGF beta 3, RN1001
Intradermal Juvista at 50ng/100μl/cm2 of SSG donor sites (3cm2) once just prior to wounding
PlaceboDrug
Intradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding
AvoterminDrug
Also called Juvista, TGF beta 3, RN1001
Intradermal Juvista at 50ng/100μl/cm2 of SSG donor site once just prior to wounding, followed by topical Juvista at 100ng/200μl/cm2 after wounding and again at Day 1
PlaceboDrug
Intradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Juvista | Experimental | Not described Receives: Drug: Avotermin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Intradermal and topical Juvista | Experimental | Not described Receives: Drug: Avotermin |
| Intradermal and topical placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the accelerated-healing potential of injection or injection plus topical application of Juvista in a male population undergoing minor split skin grafts (SSG)
Measured: Up to 12 months
Secondary outcomes (3)
To assess the local safety and toleration of injection of Juvista or injection and topical application of Juvista at the SSG donor site in a healthy male population
Measured: Up to 12 months
To assess systemic exposure following injection of Juvista or injection plus topical application of Juvista after SSG
Measured: Up to 12 months
To assess the anti-scarring potential of injection or injection and topical application of Juvista in a male population
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startOct 2003
- Primary completionJan 2006
- Study completionJan 2006
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathan Duncan, Principal investigator, RenovoJeremy Bond, Principal investigator, RenovoJames Bush, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984503
- Sponsor's protocol ID
- RN1001-319-1007
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, Randomised, Double-blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure, Accelerated Healing and Anti-scarring Potential of Juvista in Split Skin Graft Donor Sites in Male Subjects Aged 18-85 Years
- ClinicalTrials.gov ID
- NCT00984503
- Acronym / sponsor ID
- RN1001-319-1007
- Conditions
- Cicatrix, Wound Healing
- Keywords
- Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 25 Sep 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.
The purpose of this study is to investigate the accelerated-healing potential of injection or injection plus topical application of Juvista to minor split skin grafts (SSG).
Detailed description
Subjects were allocated into three groups (Group 1, Group 2 and Group 3) with all subjects receiving two 3cm2 SSG donor sites, one to each side of the lower back. Before wounding on Day 0, each site was randomised to receive either an intradermal injection of Juvista (50ng/100μl/cm2), an intradermal injection of Placebo (100μl/cm2) or no injection (Standard Care). After wounding, subjects allocated to Group 2 and Group 3 also received topical Juvista (100ng/200μl/cm2), topical Placebo (200μl/cm2) or Standard Care (Tegaderm dressing only). Topical Juvista and Placebo were held within a Granuflex ring dressing and sealed with a sterile Tegaderm dressing.
On Day 1, subjects in Group 2 and Group 3 received a further topical application of Juvista, Placebo or Standard Care according to the same treatment randomisation as Day 0.
Punch biopsy samples of healing SSG donor sites were harvested from Group 3 subjects on Day 3, 5, 7 or 10, and preserved for histological analysis.
The final study visit for Group 3 subjects was the day of the biopsy visit. Subjects in Group 1 and Group 2 underwent scar assessments at the first follow-up at Month 1 and at Months 2, 3, 4, 5, 6, 9 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intradermal Juvista | Experimental | Drug: Avotermin |
| Placebo | Placebo comparator | Drug: Placebo |
| Intradermal and topical Juvista | Experimental | Drug: Avotermin |
| Intradermal and topical placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically healthy, male subjects aged 18-85 years
- Weight between 40 and 150kg or a BMI within the permitted range for their height using Quetelet's index, 15-55 kg/m2. Weight (kg)/height (m)2.
Key exclusion criteria (16 listed)
- Subjects who had a history or evidence of hypertrophic or keloid scarring or had tattoos or previous scars in the area of the prospective SSG donor sites
- Subjects who had received surgery to the area of the lower back/buttocks in the previous 12 months
- Afro-Caribbean subjects were excluded because of their increased susceptibility to hypertrophic and keloid scarring
- Subjects who had evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, immunomediated conditions, skin diseases and allergies (such as clinically significant eczema
- Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine, allergy to surgical dressings used in this trial or to any excipients or vehicle in the formulation or delivery vehicle
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, TGF beta 3, RN1001Intradermal Juvista at 50ng/100μl/cm2 of SSG donor sites (3cm2) once just prior to wounding | Drug | Intradermal Juvista |
| PlaceboIntradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding | Drug | Placebo |
| AvoterminAlso: Juvista, TGF beta 3, RN1001Intradermal Juvista at 50ng/100μl/cm2 of SSG donor site once just prior to wounding, followed by topical Juvista at 100ng/200μl/cm2 after wounding and again at Day 1 | Drug | Intradermal and topical Juvista |
| PlaceboIntradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1 | Drug | Intradermal and topical placebo |
Primary outcome
To assess the accelerated-healing potential of injection or injection plus topical application of Juvista in a male population undergoing minor split skin grafts (SSG)
Time frame: Up to 12 months
3 secondary outcomes
To assess the local safety and toleration of injection of Juvista or injection and topical application of Juvista at the SSG donor site in a healthy male population
Time frame: Up to 12 months
To assess systemic exposure following injection of Juvista or injection plus topical application of Juvista after SSG
Time frame: Up to 12 months
To assess the anti-scarring potential of injection or injection and topical application of Juvista in a male population
Time frame: Up to 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 25 Sep 2009.
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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.
Jonathan Duncan principal investigator
Renovo
Jeremy Bond principal investigator
Renovo
James Bush 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 and Wound Healing, 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 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 25 Sep 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. 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?
To assess the accelerated-healing potential of injection or injection plus topical application of Juvista in a male population undergoing minor split skin grafts (SSG) (time frame: Up to 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 25 Sep 2009.