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

NCT ID: NCT00594581

Last Updated: 2008-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2005-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

2

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Other Intervention Names

Juvista; RN1001; Avotermin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Renovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Renovo

Principal Investigators

Jim Bush, MBChB

Role: PRINCIPAL_INVESTIGATOR

Renovo Ltd

Locations

Clinical Trials Unit, Renovo Ltd

Manchester, La, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 21042116 (View on PubMed)

Other Identifiers

RN1001-319-1011

Identifier Type: -

Identifier Source: org_study_id