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Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males

Primary Purpose

Cicatrix

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Juvista (avotermin) plus placebo, standard-care (within-subject controls)

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring cicatrix, scarring, TGF-beta3, avotermin, Juvista

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Clinically healthy, male subjects aged 18 to 45 years (inclusive)
Body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using Quetelet's index

Exclusion Criteria:

Subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied.
Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial.
Afro-Caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring.
Subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease.
Subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial.
Subjects with a history of clinically significant allergies.
Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination.
Subjects taking, or who had taken, certain prescribed drugs in the 4 weeks before to Day 0 and, in particular, topical or systemic steroids, anti-inflammatory, anti-coagulant, anti-proliferative drugs, and antibiotics.
Subjects who have taken part in a clinical trial within 3 months before admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not.
Subjects with any clinical evidence of severe ongoing, or prolonged, depression or mental illness.
Subjects smoking more than 20 cigarettes a day.
Subjects drinking more than 28 units of alcohol per week (1 unit = ½ pint of beer [285ml], 25ml of spirits, or 1 glass of wine).
Subjects showing evidence of drug abuse.
Subjects known to have, or to have had, serum hepatitis or who were carriers of the hepatitis B surface antigen (HbsAg) or hepatitis C antibody.
Subjects previously testing positive for HIV antibodies, or who admit to belonging to a high-risk group.
Subjects with pre-existing clinically significant neurological conditions.
Subjects who, in the opinion of an investigator, are not likely to complete the trial for whatever reason.

Sites / Locations

Clinical Trials Unit, Renovo Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Juvista (avotermin) 50ng/100μl/linear cm wound margin

Juvista (avotermin) at 200ng/100μl/linear cm

Outcomes

Primary Outcome Measures

Scar appearance

Secondary Outcome Measures

Safety: adverse events, local tolerability, systemic exposure

Full Information

NCT ID

NCT00594581

First Posted

December 11, 2007

Last Updated

January 2, 2008

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00594581

Brief Title

Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males

Official Title

A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal Juvista (Avotermin) in Male Subjects Aged 18-45 Years

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.

6. Conditions and Keywords

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

Cicatrix

Keywords

cicatrix, scarring, TGF-beta3, avotermin, Juvista

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Juvista (avotermin) 50ng/100μl/linear cm wound margin

Arm Title

Arm Type

Active Comparator

Arm Description

Juvista (avotermin) at 200ng/100μl/linear cm

Intervention Type

Drug

Intervention Name(s)

Juvista (avotermin) plus placebo, standard-care (within-subject controls)

Other Intervention Name(s)

Juvista, RN1001, Avotermin

Intervention Description

Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin

Primary Outcome Measure Information:

Title

Scar appearance

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Safety: adverse events, local tolerability, systemic exposure

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically healthy, male subjects aged 18 to 45 years (inclusive) Body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using Quetelet's index Exclusion Criteria: Subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied. Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial. Afro-Caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring. Subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease. Subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial. Subjects with a history of clinically significant allergies. Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination. Subjects taking, or who had taken, certain prescribed drugs in the 4 weeks before to Day 0 and, in particular, topical or systemic steroids, anti-inflammatory, anti-coagulant, anti-proliferative drugs, and antibiotics. Subjects who have taken part in a clinical trial within 3 months before admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not. Subjects with any clinical evidence of severe ongoing, or prolonged, depression or mental illness. Subjects smoking more than 20 cigarettes a day. Subjects drinking more than 28 units of alcohol per week (1 unit = ½ pint of beer [285ml], 25ml of spirits, or 1 glass of wine). Subjects showing evidence of drug abuse. Subjects known to have, or to have had, serum hepatitis or who were carriers of the hepatitis B surface antigen (HbsAg) or hepatitis C antibody. Subjects previously testing positive for HIV antibodies, or who admit to belonging to a high-risk group. Subjects with pre-existing clinically significant neurological conditions. Subjects who, in the opinion of an investigator, are not likely to complete the trial for whatever reason.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jim Bush, MBChB

Organizational Affiliation

Renovo Ltd

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Trials Unit, Renovo Ltd

City

Manchester

State/Province

ZIP/Postal Code

M13 9XX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21042116

Citation

Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.

Results Reference

derived

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Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males

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