Scars Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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