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

2014-08-27 03:19:04 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cicatrix

Intervention

Prevascar, Prevascar, Prevascar, Prevascar, Prevascar, Prevascar, Prevascar, Prevascar, Placebo

Location

Renovo
Manchester
United Kingdom
M13 9XX

Status

Completed

Source

Renovo

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:04-0400

Clinical Trials [1 Associated Clinical Trials listed on BioPortfolio]

Prevascar in African Continental Group Scarring

There is considerable variation in scarring, within and between people, and between different ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than th...

PubMed Articles [0 Results]

None

Medical and Biotech [MESH] Definitions

None available.

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