- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847925
Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects
February 18, 2009 updated by: Renovo
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
Study Overview
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 Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 2
- Phase 1
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
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Manchester, United Kingdom, M13 9XX
- Renovo CTU
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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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A
50ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: B
20ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: C
5ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: D
100ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: E
500ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: F
0.25ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: G
1ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: H
20ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
Other: I
50ng Avotermin/100ul
|
100ul/linear cm of wound.
Dosed before surgery and 24h later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scar severity
Time Frame: 12 Months
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment local and systemic tolerance
Time Frame: 12 Months
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Duncan, MB BCh, Renovo
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
November 1, 2001
Primary Completion (Actual)
September 1, 2003
Study Completion (Actual)
September 1, 2003
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 18, 2009
First Posted (Estimate)
February 19, 2009
Study Record Updates
Last Update Posted (Estimate)
February 19, 2009
Last Update Submitted That Met QC Criteria
February 18, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RN1001-309-1002
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.
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