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

Primary Purpose

Cicatrix

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Avotermin

Placebo

About this trial

This is an interventional basic science trial for Cicatrix

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Renovo CTU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Arm Description

5ng Avotermin

50ng Avotermin

100ng Avotermin

Placebo

Standard Care

Outcomes

Primary Outcome Measures

Evaluation of scar appearance by an independent panel

Secondary Outcome Measures

Histological evaluation of wound healing

Adverse event occurance

Full Information

NCT ID

NCT00847795

First Posted

February 18, 2009

Last Updated

February 18, 2009

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00847795

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

September 2002 (undefined)

Primary Completion Date

June 2003 (Actual)

Study Completion Date

June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cicatrix

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

5ng Avotermin

Arm Title

Arm Type

Experimental

Arm Description

50ng Avotermin

Arm Title

Arm Type

Experimental

Arm Description

100ng Avotermin

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

No Intervention

Arm Description

Standard Care

Intervention Type

Drug

Intervention Name(s)

Avotermin

Other Intervention Name(s)

Juvista

Intervention Description

Intradermal administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Evaluation of scar appearance by an independent panel

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Histological evaluation of wound healing

Time Frame

3 days

Title

Adverse event occurance

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Duncan, BS BCh

Organizational Affiliation

Renovo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renovo CTU

City

Manchester

ZIP/Postal Code

M13 9XX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

19362676

Citation

Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.

Results Reference

derived

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

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