Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects
To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.
|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|
- 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 ]
- 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 ]
|Study Start Date:||April 2003|
|Study Completion Date:||August 2004|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
|Experimental: Intradermal avotermin||
Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Other Names:Drug: Avotermin
Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
|Placebo Comparator: Placebo||
Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1
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.