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

Sponsor

Renovo (Industry)

Overall Status

Completed

CT.gov ID

NCT00984581

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cicatrix Wound Healing	Drug: Avotermin Drug: Avotermin Drug: Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group. [Month 6]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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