Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.
This study has been completed.
Sponsor:
Renovo
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00847795
First received: February 18, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cicatrix |
Drug: Avotermin Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Renovo:
Primary Outcome Measures:
- Evaluation of scar appearance by an independent panel [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Histological evaluation of wound healing [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- Adverse event occurance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 42 |
| Study Start Date: | September 2002 |
| Study Completion Date: | June 2003 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
5ng Avotermin
|
Drug: Avotermin
Intradermal administration
Other Name: Juvista
|
|
Experimental: 2
50ng Avotermin
|
Drug: Avotermin
Intradermal administration
Other Name: Juvista
|
|
Experimental: 3
100ng Avotermin
|
Drug: Avotermin
Intradermal administration
Other Name: Juvista
|
|
Placebo Comparator: 4
Placebo
|
Drug: Placebo
Placebo
|
|
No Intervention: 5
Standard Care
|
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
No publications provided by Renovo
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mark Cooper, Renovo Ltd |
| ClinicalTrials.gov Identifier: | NCT00847795 History of Changes |
| Other Study ID Numbers: | RN1001-319-1005 |
| Study First Received: | February 18, 2009 |
| Last Updated: | February 18, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on September 26, 2012
