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

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00984581
First received: September 15, 2009
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Cicatrix
Wound Healing
Drug: Avotermin
Drug: Placebo
Phase 1
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: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess systemic exposure following intradermal Juvista before and after minor skin incisions. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • To assess the anti-scarring potential of intradermal Juvista in a young female population. [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intradermal avotermin Drug: Avotermin
Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Other Names:
  • TGFbeta 3
  • Juvista
Drug: Avotermin
Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Other Names:
  • TGFbeta 3
  • Juvista
Placebo Comparator: Placebo Drug: Placebo
Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00984581

Locations
United Kingdom
Renovo
Manchester, United Kingdom, M13 9XX
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: Jonathan Duncan Renovo
Principal Investigator: Jeremy Bond Renovo
  More Information

No publications provided

Responsible Party: John Hutchison, Medical Director, Renovo Ltd
ClinicalTrials.gov Identifier: NCT00984581     History of Changes
Other Study ID Numbers: RN1001-319-1006
Study First Received: September 15, 2009
Last Updated: September 24, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Renovo:
Cicatrix
Scar
Wound healing
Avotermin
TGF beta 3
Juvista
RN1001

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014