Wound Healing Clinical Trial
Official title:
A Single-centre, Placebo- and Standard-care-controlled, Double-blind, Randomised Trial to Investigate the Efficacy of Eight Doses of RN1003 in the Reduction of Scarring From the Approximated Wound Margins of Incisional Wounds
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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