NCT00821457

Juvista in the Non-surgical Improvement of Existing Scars

A Within Patient, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy of Juvista in Improving the Appearance of Existing Scars That Are 2-6 Months Old

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Juvista	250ng
DRUG	Placebo	Powder for solution for injection
DRUG	Juvista	500ng

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-01-13
• Last updated: 2010-03-09

Locations

1 site across 1 country: United Kingdom