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

Cicatrix Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594581
• Other study ID #: RN1001-319-1011
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2007
• Last updated: January 2, 2008
• Start date: October 2003
• Est. completion date: March 2005

Study information

• Verified date: January 2008
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Clinical Trials Unit, Renovo Ltd	Manchester	La

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar appearance		12 months	No
Secondary	Safety: adverse events, local tolerability, systemic exposure		12 months	Yes