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

NCT00594581 | Completed Phase 2

• 1 other identifier: RN1001-319-1011
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix

Keywords

cicatrix, scarring, TGF-beta3, avotermin, Juvista

Outcome Measures

Primary Outcomes (1)

• Scar appearance

  12 months

Secondary Outcomes (1)

• Safety: adverse events, local tolerability, systemic exposure

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

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

2

ACTIVE COMPARATOR

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

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

Interventions

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

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

Also known as: Juvista, RN1001, Avotermin

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Clinical Trials Unit, Renovo Ltd

Manchester, La, M13 9XX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21042116 DERIVED

MeSH Terms

Conditions

Cicatrix; Arrhythmogenic Right Ventricular Dysplasia, Familial, 1

Interventions

TGFB3 protein, human; Standard of Care

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jim Bush, MBChB

  Renovo Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: January 15, 2008
• Study Start: October 1, 2003
• Study Completion: March 1, 2005
• Last Updated: January 15, 2008

Record last verified: 2008-01

Locations

GB (1)