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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00594581
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : January 15, 2008
Information provided by:

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
Drug Information available for: Avotermin

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594581

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United Kingdom
Clinical Trials Unit, Renovo Ltd
Manchester, La, United Kingdom, M13 9XX
Sponsors and Collaborators
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Principal Investigator: Jim Bush, MBChB Renovo Ltd
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Keywords provided by Renovo:
cicatrix, scarring, TGF-beta3, avotermin, Juvista
Additional relevant MeSH terms:
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Pathologic Processes