CicatrixPhase 2NCT00984646
Investigation Into the Scar Reduction Potential of Prevascar (Interleukin-10)
A Phase 2 study testing Prevascar in people with Cicatrix and Wound Healing, run by Renovo at 1 site in United Kingdom.
Trial summary
The purpose of this study was to investigate the scar-reducing properties of eight doses of intradermal Prevascar (IL-10). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Wound Healing
- What is being tested?
- Prevascar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Nov 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects, aged 18-85 years, who have given written informed consent
- Subjects with a BMI (Quetelet's index) within the permitted weight/height2 range of 15-55kg/m2
- Subjects with, in the opinion of the Investigator, clinically acceptable results for screening laboratory tests performed within 28 days prior to the first trial administration
- Female subjects with child-bearing potential who are using a method(s) of contraception deemed acceptable by the Investigator and agree to continue doing so for the first month of the trial
Who cannot join
- Subjects who, on direct questioning and by physical examination, reveal a history or evidence of hypertrophic or keloid scarring
- Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial
- Subjects of Afro-Caribbean descent, because of their increased susceptibility to hypertrophic or keloid scarring
- Subjects who have had previous surgery in the area to be incised, conducted within 1 year of the first dosing day
- Subjects with a history of a bleeding disorder or who are receiving anticoagulant therapy
- Subjects who, on direct questioning and physical examination, show evidence of any past or present clinically significant disease that may affect the endpoints of the trial, e.g. coagulation disorders, diabetes, immuno- mediated conditions and clinically significant skin diseases or allergies
Show all 19Show fewer
- Subjects with a clinically significant skin disorder that is chronic or currently active, and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial
- Subjects with any clinically significant medical condition or history that would impair wound healing, including significant rheumatoid arthritis, chronic renal impairment (significant for age), significant hepatic impairment (liver function tests >3 times upper limit of normal), congestive heart failure, active malignancy or history of malignancy within last 5 years, immunosuppression or chemotherapy within last 12 months, history of radiotherapy or diabetes mellitus
- Subjects with a history of hypersensitivity to any of the drugs or dressings used in the trial
- Subjects who are taking, or who have taken, any investigational product or participated in a clinical trial within 3 months prior to the 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 who test positive for drugs of abuse (cocaine, amphetamines, methamphetamines, opiates or benzodiazepines) during the screening period, which is not explained by the intake of legitimate prescribed or over-the-counter medication for a documented medical condition
- Subjects who, in the opinion of the Investigator, are unlikely to complete the trial for whatever reason
- Subjects receiving immunosuppressive treatment
- Females who are pregnant or lactating
- Subjects who have any clinically significant neurological impairment or disease
- Subjects with an active infection (subjects were able to participate in the trial once the infection had passed and they had been re-screened)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Placebo- and Standard-care-controlled, Double-blind, Randomised Trial to Investigate the Efficacy of Eight Doses of RN1003 in the Reduction of Scarring From the Approximated Wound Margins of Incisional Wounds
The purpose of this study was to investigate the scar-reducing properties of eight doses of intradermal Prevascar (IL-10).
Read the detailed description
Subjects were randomised to one of two dose groups, each with four concentrations of intradermal Prevascar. Subjects had four 1cm incisional wounds made on the inner aspect of each upper arm (eight in total), giving four sets of anatomically paired wound sites per subject. Each subject acted as their own control with one site from each wound pair randomly treated with intradermal Prevascar and the other treated with Placebo (vehicle) or Standard Care.
Intradermal Prevascar was administered at 100μl per linear cm of wound site prior to wounding on Day 0 and 100μl per linear cm to each wound margin 24 hours later on Day 1. Group 1 subjects received doses of 5, 50, 250 and 1000ng/100μl and group 2 subjects received 25, 125, 500 and 2000ng/100μl.
Subjects in each group were also randomised into two control subgroups to receive either 100μl/linear cm intradermal placebo (Subgroup 1) or Standard Care alone (Subgroup 2) at control wound sites.
Subjects returned for follow-up at Day 14, Month 1, Month 3, Month 6, Month 9 and Month 12.
- Conditions
- Cicatrix, Wound Healing
- Being tested
- Prevascar, Placebo
- Keywords
- Cicatrix, Scar, Wound-healing, Prevascar, Interleukin-10 (IL-10), Ilodecakin, RN1003
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PrevascarDrug
Also called IL-10, Ilodecakin, RN1003
Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
PlaceboDrug
Intradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Prevascar | Experimental | Not described Receives: Drug: Prevascar |
| Placebo (vehicle) | 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 establish which of eight intradermal doses of RN1003 has the greatest scar-reducing properties, compared with Placebo and Standard Care.
Measured: 12 months
Secondary outcomes (2)
To collect further safety and tolerability data for RN1003
Measured: 12 months
To assess pre- and post-dose systemic levels of RN1003.
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 posted25 Sep 2009 (estimated)
- Study startApr 2005
- Primary completionNov 2006
- Study completionNov 2006
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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Bush, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984646
- Sponsor's protocol ID
- RN1003-0027
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Do NN, Willenborg S, Eckes B, Jungst C, Sengle G, Zaucke F, Eming SA. Myeloid Cell-Restricted STAT3 Signaling Controls a Cell-Autonomous Antifibrotic Repair Program. J Immunol. 2018 Jul 15;201(2):663-674. doi: 10.4049/jimmunol.1701791. Epub 2018 Jun 13.
PubMed 29898959
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-centre, Placebo- and Standard-care-controlled, Double-blind, Randomised Trial to Investigate the Efficacy of Eight Doses of RN1003 in the Reduction of Scarring From the Approximated Wound Margins of Incisional Wounds
- ClinicalTrials.gov ID
- NCT00984646
- Acronym / sponsor ID
- RN1003-0027
- Conditions
- Cicatrix, Wound Healing
- Keywords
- Cicatrix, Scar, Wound-healing, Prevascar, Interleukin-10 (IL-10), Ilodecakin, RN1003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 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 was to investigate the scar-reducing properties of eight doses of intradermal Prevascar (IL-10).
Detailed description
Subjects were randomised to one of two dose groups, each with four concentrations of intradermal Prevascar. Subjects had four 1cm incisional wounds made on the inner aspect of each upper arm (eight in total), giving four sets of anatomically paired wound sites per subject. Each subject acted as their own control with one site from each wound pair randomly treated with intradermal Prevascar and the other treated with Placebo (vehicle) or Standard Care.
Intradermal Prevascar was administered at 100μl per linear cm of wound site prior to wounding on Day 0 and 100μl per linear cm to each wound margin 24 hours later on Day 1. Group 1 subjects received doses of 5, 50, 250 and 1000ng/100μl and group 2 subjects received 25, 125, 500 and 2000ng/100μl.
Subjects in each group were also randomised into two control subgroups to receive either 100μl/linear cm intradermal placebo (Subgroup 1) or Standard Care alone (Subgroup 2) at control wound sites.
Subjects returned for follow-up at Day 14, Month 1, Month 3, Month 6, Month 9 and Month 12.
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 |
|---|---|---|
| Intradermal Prevascar | Experimental | Drug: Prevascar |
| Placebo (vehicle) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects, aged 18-85 years, who have given written informed consent
- Subjects with a BMI (Quetelet's index) within the permitted weight/height2 range of 15-55kg/m2
- Subjects with, in the opinion of the Investigator, clinically acceptable results for screening laboratory tests performed within 28 days prior to the first trial administration
- Female subjects with child-bearing potential who are using a method(s) of contraception deemed acceptable by the Investigator and agree to continue doing so for the first month of the trial
Key exclusion criteria (19 listed)
- Subjects who, on direct questioning and by physical examination, reveal a history or evidence of hypertrophic or keloid scarring
- Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial
- Subjects of Afro-Caribbean descent, because of their increased susceptibility to hypertrophic or keloid scarring
- Subjects who have had previous surgery in the area to be incised, conducted within 1 year of the first dosing day
- Subjects with a history of a bleeding disorder or who are receiving anticoagulant therapy
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 |
|---|---|---|
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PrevascarAlso: IL-10, Ilodecakin, RN1003Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Intradermal Prevascar |
| PlaceboIntradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later | Drug | Placebo (vehicle) |
Primary outcome
To establish which of eight intradermal doses of RN1003 has the greatest scar-reducing properties, compared with Placebo and Standard Care.
Time frame: 12 months
2 secondary outcomes
To collect further safety and tolerability data for RN1003
Time frame: 12 months
To assess pre- and post-dose systemic levels of RN1003.
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 25 Sep 2009.
- Derived from this study: PubMed 29898959Do NN, Willenborg S, Eckes B, Jungst C, Sengle G, Zaucke F, Eming SA. Myeloid Cell-Restricted STAT3 Signaling Controls a Cell-Autonomous Antifibrotic Repair Program. J Immunol. 2018 Jul 15;201(2):663-674. doi: 10.4049/jimmunol.1701791. Epub 2018 Jun 13.
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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 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 Prevascar 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 4 inclusion and 19 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 establish which of eight intradermal doses of RN1003 has the greatest scar-reducing properties, compared with Placebo and Standard Care. (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 NCT00984646, 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 25 Sep 2009.