NCT00984646

Investigation Into the Scar Reduction Potential of Prevascar (Interleukin-10)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to investigate the scar-reducing properties of eight doses of intradermal Prevascar (IL-10).

Detailed description

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.

Conditions

• Cicatrix
• Wound Healing

Interventions

Type	Name	Description
DRUG	Prevascar	Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Prevascar	Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Prevascar	Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Prevascar	Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Prevascar	Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Prevascar	Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Prevascar	Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Prevascar	Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
DRUG	Placebo	Intradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2009-09-25
• Last updated: 2009-09-25

Locations

1 site across 1 country: United Kingdom