The purpose of this study was to investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only or three times in male and female subjects and to collect further safety and tolerability data for intradermal Juvidex in male and female subjects.
Subjects were randomised into three dose groups of equal size. The three dose groups were 100mM (2.82mg/100μl), 200mM (5.64mg/100μl) and 400mM (11.28mg/100μl). Before wounding, three prospective wound sites 1cm long were marked on the upper, inner aspect of each arm (anterior, posterior and distal) to give three pairs of wounds. Wounds were assigned as Pair 1 (left distal and right distal), Pair 2 (left anterior and left posterior) and Pair 3 (right anterior and right posterior). Sites were anaesthetised using 1% plain lignocaine, then prior to wounding one site from each pair, randomly assigned, received an intradermal injection of Juvidex (100μl) and the opposite site from each pair received an intradermal injection of Placebo (100μl). Within dose groups, subjects were randomised into two subgroups of similar size. Subgroup A received one dose in wound pairs 1 and 2; and three doses in wound pair 3. Subgroup B received three doses in wound pairs 1 and 2; and one dose in wound pair 3. Incision sites randomised to receive three injections of study medication were re-dosed with 100μl per wound margin (200μl per site) 3 hours after receiving the first dose and dosed again in the same way on Day 5. Subjects attended a follow-up visit on Day 14. Scars were assessed monthly from Month 1 to Month 12. At Month 12, the Investigator excised the distal scars from each subject for histological examination. Posttrial follow-up visits are scheduled for Months 18 and 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding
Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding
Renovo
Manchester, United Kingdom
To investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only and three times in male and female subjects.
Time frame: 12 months
To collect further safety and tolerability data for various doses and dosing frequencies of intradermal Juvidex in male and female subjects.
Time frame: 1 hour to 24 months
To assess systemic exposure to Juvidex, following various doses and dosing frequencies of intradermal Juvidex, before and after making minor skin incisions in male and female subjects.
Time frame: 1 hour to 12 months
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Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding
Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
Intradermal Placebo, 100μl administered once prior to wounding
Intradermal Placebo, 100μl administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)