Investigation Into the Scar Reduction Potential of Prevascar (Interleukin-10)
September 24, 2009 updated by: Renovo
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).
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
175
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Manchester, United Kingdom, M13 9XX
- Renovo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo (vehicle)
|
Intradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
|
|
Experimental: Intradermal Prevascar
|
Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To collect further safety and tolerability data for RN1003
Time Frame: 12 months
|
12 months
|
|
To assess pre- and post-dose systemic levels of RN1003.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
September 24, 2009
First Submitted That Met QC Criteria
September 24, 2009
First Posted (Estimate)
September 25, 2009
Study Record Updates
Last Update Posted (Estimate)
September 25, 2009
Last Update Submitted That Met QC Criteria
September 24, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RN1003-0027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.