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

• ClinicalTrials.gov Identifier: NCT00594581
• Recruitment Status: Completed
• First Posted: January 15, 2008
• Last Update Posted: January 15, 2008
• Sponsor: Renovo
• Information provided by: Renovo

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.

Condition or disease	Intervention/treatment	Phase
Cicatrix	Drug: Juvista (avotermin) plus placebo, standard-care (within-subject controls)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: October 2003
• Actual Study Completion Date: March 2005

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; 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; Other Names: Juvista; RN1001; Avotermin
Active Comparator: 2; 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; Other Names: Juvista; RN1001; Avotermin

Outcome Measures

Primary Outcome Measures :

1. Scar appearance [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Safety: adverse events, local tolerability, systemic exposure [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes 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

Locations

United Kingdom

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Mark Cooper, SVP of Clinical Operations, Renovo
• ClinicalTrials.gov Identifier: NCT00594581
• Other Study ID Numbers: RN1001-319-1011
• First Posted: January 15, 2008
• Last Update Posted: January 15, 2008
• Last Verified: January 2008

Keywords provided by Renovo:

cicatrix, scarring, TGF-beta3, avotermin, Juvista

Additional relevant MeSH terms:

Cicatrix; Fibrosis; Pathologic Processes