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

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00594581
First received: December 11, 2007
Last updated: January 2, 2008
Last verified: January 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Renovo

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

Keywords provided by Renovo:
cicatrix, scarring, TGF-beta3, avotermin, Juvista

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014