Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects

September 24, 2009 updated by: Renovo

A Single-site, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and Anti-scarring Potential of Intradermal Juvista in Female Subjects Aged 18-45 Years

To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects were to receive two 1cm incisions on the upper, inner aspect of each arm (four wounds per subject).

On Day 0 all subjects received intradermal Juvista at a concentration of 50ng/100ul to one incision site on Arm 1 and 5ng/100ul to one incision site on Arm 2. The other incision sites were injected with placebo. Following injection, 1cm incision wounds were made at each site.

On Day 1 all subjects were re-injected with 100ul/cm intradermal Juvista or placebo to each side of the wound (200ul per incision) at the same concentration as for Day 0 (50 or 5ng/100ul).

At month 6 all incision sites were excised for histological analysis and all excision sites injected with Juvista. Both sites on Arm 1 received 50ng/100ul/linear cm wound margin and both sites on Arm 2 received 5ng/100ul/linear cm wound margin. No excision sites received placebo.

The appearance of excision scars was then assessed after 2, 4 and 6 months of healing i.e at months 8, 10 and 12 of the study.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinically healthy, female subjects aged 18-45 years
  • Weight between 40-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-35 kg/m(squared)). Weight(kg)/height (squared)(m)
  • Subjects who use appropriate non-pharmaceutical methods of contraception or are not likely to become pregnant for the duration of the trial

Exclusion Criteria:

  • Subjects who have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied
  • Subjects with a personal history of a bleeding disorder
  • Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
  • Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial
  • Subjects with any clinically significant medical condition that would impair wound healing including significant rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled digestive heart failure, active malignancy, immunosuppressive, radiation or chemotherapy within the last three months, a history of radiotherapy to the arm or diabetes mellitus
  • Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial
  • Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination
  • Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, HRT, oral contraceptive pill, other pharmaceutical methods of contraception or anticoagulant drugs in the thirty days prior to Day 0
  • Subjects who have evidence of drug abuse
  • Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against hepatitis B are not excluded per se
  • Subjects who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs
  • Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high risk group and subjects who at any point have a positive pregnancy test
  • Subjects who are pregnant or become pregnant during the trial
  • In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1
Experimental: Intradermal avotermin
Drug: Avotermin
Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Other Names:
  • Juvista
  • TGFbeta 3
Drug: Avotermin
Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Other Names:
  • Juvista
  • TGFbeta 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess systemic exposure following intradermal Juvista before and after minor skin incisions.
Time Frame: Month 6
Month 6
To assess the anti-scarring potential of intradermal Juvista in a young female population.
Time Frame: Month 6-12
Month 6-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 25, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN1001-319-1006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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