Juvista in the Non-surgical Improvement of Existing Scars
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- The primary efficacy variable is the change in scar appearance at 6 months post treatment, assessed by calculating the colour difference between the treated scar sections with reference to the surrounding skin. [ Time Frame: 6 months post treatment ] [ Designated as safety issue: No ]
- The secondary efficacy variable is the difference in scar appearance between active and placebo treated segments at 6 months post treatment as assessed using a global scar comparison scale [ Time Frame: 6 months post treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||March 2010|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Group 1
250ng Juvista vs placebo
Other Names:Drug: Placebo
Powder for solution for injection
Active Comparator: Group 2
500 ng Juvista vs placebo
Powder for solution for injectionDrug: Juvista