MedTrace Logo

Juvista in the Non-surgical Improvement of Existing Scars

NCT00821457 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-03-09

No results posted yet for this study

Summary

Renovo, a Biopharmaceutical company involved in the development of drugs to improve the appearance of scars and enhance wound healing, are proposing to carry out research in improving the appearance of existing scars that are 2-6 months old using Juvista. Juvista has not previously been administered to pre-existing scars without surgical revision, but it is thought that some beneficial effects seen with Juvista in previous trials may also be seen when administered to existing scars whilst the scar is maturing. This proof of concept study will therefore investigate the effect of Juvista in Caucasian male and female patients when administered to scars that are between two and six months old.

Scarring in the skin can vary hugely between individuals; therefore the most reliable way to assess the efficacy of an improvement of scar appearance is to use a model where each patient acts as their own control. A placebo will also be used for this trial as there are currently no approved pharmaceuticals for the improvement of scarring.

A total of 20 patients will be allocated to one of two dosing groups. Patients who enter the study will have linear scars resulting from broken skin (e.g. trauma, surgery) between 7 and 20cm in length, as well as meeting other specific criteria. The scar to be treated will be divided into two equal segments. Each segment will receive an intradermal injection of Juvista or placebo on Day 0 and 24 hours later.

The measure of change in scar appearance will be performed using colour analysis which will assess the change in colour between the Juvista treated segments versus the placebo treated segment of the scar, with reference to the surrounding skin within each patient.

Conditions

  • Scars

Interventions

DRUG

Juvista

250ng

DRUG

Placebo

Powder for solution for injection

DRUG

Juvista

500ng

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • James Dr Bush, MBChB MRCS · Renovo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821457 on ClinicalTrials.gov