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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cicatrix

Intervention / Treatment
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* Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Juvista (avotermin) 50ng/100μl/linear cm wound margin | Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)<br>* Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin<br>* Other names: Avotermin;|
| Active Comparator: 2<br>Juvista (avotermin) at 200ng/100μl/linear cm | Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)<br>* Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin<br>* Other names: Avotermin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: adverse events, local tolerability, systemic exposure |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cicatrix, scarring, TGF-beta3, avotermin, Juvista