Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cicatrix

Intervention / Treatment
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* Drug: Avotermin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>5ng Avotermin | Drug: Avotermin<br>* Intradermal administration<br>* Other names: Juvista;|
| Experimental: 2<br>50ng Avotermin | Drug: Avotermin<br>* Intradermal administration<br>* Other names: Juvista;|
| Experimental: 3<br>100ng Avotermin | Drug: Avotermin<br>* Intradermal administration<br>* Other names: Juvista;|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| No Intervention: 5<br>Standard Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of scar appearance by an independent panel |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological evaluation of wound healing |  | 3 days | 
| Adverse event occurance |  | 6 months |