The purpose of this study was to investigate the scar-reducing properties of eight doses of intradermal Prevascar (IL-10).
Subjects were randomised to one of two dose groups, each with four concentrations of intradermal Prevascar. Subjects had four 1cm incisional wounds made on the inner aspect of each upper arm (eight in total), giving four sets of anatomically paired wound sites per subject. Each subject acted as their own control with one site from each wound pair randomly treated with intradermal Prevascar and the other treated with Placebo (vehicle) or Standard Care. Intradermal Prevascar was administered at 100μl per linear cm of wound site prior to wounding on Day 0 and 100μl per linear cm to each wound margin 24 hours later on Day 1. Group 1 subjects received doses of 5, 50, 250 and 1000ng/100μl and group 2 subjects received 25, 125, 500 and 2000ng/100μl. Subjects in each group were also randomised into two control subgroups to receive either 100μl/linear cm intradermal placebo (Subgroup 1) or Standard Care alone (Subgroup 2) at control wound sites. Subjects returned for follow-up at Day 14, Month 1, Month 3, Month 6, Month 9 and Month 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
175
Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Renovo
Manchester, United Kingdom
To establish which of eight intradermal doses of RN1003 has the greatest scar-reducing properties, compared with Placebo and Standard Care.
Time frame: 12 months
To collect further safety and tolerability data for RN1003
Time frame: 12 months
To assess pre- and post-dose systemic levels of RN1003.
Time frame: 12 months
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Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Intradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later