- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847795
Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.
February 18, 2009 updated by: Renovo
A Trial to Investigate the Accelerated Wound Healing and Antiscarring Potential, Safety, Toleration and Systemic Exposure of Intradermal RN1001 (Avotermin) in Male and Female Subjects Aged 60 Years and Over.
An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar prevention and reduction and acceleration of healing.
The trial has an additional objective to evaluate several different scar assessment techniques that can be used in future clinical trials in the prevention and reduction of scarring.
Study Overview
Detailed Description
Double blind, randomised, Placebo and Standard Care controlled, single centre study.
Each subject receives a total of 6 wounds, two incisions and four punch biopsies.
Each subject serves 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/scarring.
Healed scars from incisional wounds excised from Arm 1 and Arm 2 after 6 months for histological analysis.
Study Type
Interventional
Enrollment (Actual)
42
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
-
-
-
Manchester, United Kingdom, M13 9XX
- Renovo CTU
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinically healthy, male and female subjects aged 60 years and over. All females will be at least 2 years post menopausal.
- Weight between 50 and 150kg or a body mass index within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 15 - 35 kg/m2.
Exclusion Criteria:
- Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.
- Subjects with a personal history of a bleeding disorder.
- Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing the acute wounds or involves the areas to be examined in this trial.
- Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.
- Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.
- Subjects with any clinically significant abnormality following review of pre trial laboratory data and physical examination (see above).
- Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, hormone replacement therapy (HRT) or anti-coagulant drugs in the thirty days prior to Day 0.
- Subjects who have 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 trial 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: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 4
Placebo
|
Placebo
|
Experimental: 1
5ng Avotermin
|
Intradermal administration
Other Names:
|
Experimental: 2
50ng Avotermin
|
Intradermal administration
Other Names:
|
Experimental: 3
100ng Avotermin
|
Intradermal administration
Other Names:
|
No Intervention: 5
Standard Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of scar appearance by an independent panel
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Histological evaluation of wound healing
Time Frame: 3 days
|
3 days
|
Adverse event occurance
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Duncan, BS 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
September 1, 2002
Primary Completion (Actual)
June 1, 2003
Study Completion (Actual)
June 1, 2003
Study Registration Dates
First Submitted
February 18, 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
- RN1001-319-1005
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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