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

Sponsored by:	Renovo
Information provided by:	Renovo
ClinicalTrials.gov Identifier:	NCT00594581

Purpose

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.

Condition	Intervention	Phase
Cicatrix	Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Scars

Drug Information available for: Avotermin

U.S. FDA Resources

Further study details as provided by Renovo:

Primary Outcome Measures:

Scar appearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: adverse events, local tolerability, systemic exposure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	71
Study Start Date:	October 2003
Study Completion Date:	March 2005

Arms	Assigned Interventions
1: Active Comparator Juvista (avotermin) 50ng/100μl/linear cm wound margin	Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls) Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin
2: Active Comparator Juvista (avotermin) at 200ng/100μl/linear cm	Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls) Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594581

Locations

United Kingdom, La
Clinical Trials Unit, Renovo Ltd
Manchester, La, United Kingdom, M13 9XX

Sponsors and Collaborators

Renovo

Investigators

Principal Investigator:

Jim Bush, MBChB

Renovo Ltd

More Information

No publications provided

Responsible Party:	Renovo ( Mark Cooper, SVP of Clinical Operations )
Study ID Numbers:	RN1001-319-1011
Study First Received:	December 11, 2007
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00594581 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Renovo:

cicatrix, scarring, TGF-beta3, avotermin, Juvista

Study placed in the following topic categories:

Skin Diseases
Healthy
Cicatrix

Additional relevant MeSH terms:

Skin Diseases
Cicatrix

ClinicalTrials.gov processed this record on August 30, 2009