To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
35
Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1
Renovo
Manchester, United Kingdom
To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.
Time frame: Month 6
To assess systemic exposure following intradermal Juvista before and after minor skin incisions.
Time frame: Month 6
To assess the anti-scarring potential of intradermal Juvista in a young female population.
Time frame: Month 6-12
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