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

Wound Healing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984581
• Other study ID #: RN1001-319-1006
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 15, 2009
• Last updated: September 24, 2009
• Start date: April 2003
• Est. completion date: August 2004

Study information

• Verified date: September 2009
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cicatrix
• Wound Healing

Intervention

Drug:
• Avotermin
Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
• Avotermin
Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
• Placebo
Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1

Locations

Country	Name	City	State
United Kingdom	Renovo	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.		Month 6	Yes
Secondary	To assess systemic exposure following intradermal Juvista before and after minor skin incisions.		Month 6	Yes
Secondary	To assess the anti-scarring potential of intradermal Juvista in a young female population.		Month 6-12	No