Juvista in the non surgical improvement of existing scars - Version 2

• Research type

  Research Study

• Full 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.

• IRAS ID

  7149

• Contact name

  James Bush

• Sponsor organisation

  Renovo

• Eudract number

  2008-004938-24

• ISRCTN Number

  N/A

• Research summary

  Renovo, a biopharmaceutical company developing products to improve the appearance of scars and enhance wound healing, are carrying out research in improving the appearance of existing scars using Juvista. Juvista has not previously been administered to existing scars without surgical revision, but it is thought that some beneficial effects of Juvista seen in previous trials may also be seen by administering Juvista to existing scars whilst the scar is maturing. This study will investigate the effect of Juvista in Caucasian male and female patients when administered to scars that are two to 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 (a dummy treatment with no active ingredient) will also be used as there are currently no approved pharmaceuticals for the improvement of scarring. Forty patients will be equally allocated to one of two dosing groups. Patients entering the study will have a scar resulting from broken skin (e.g. trauma, surgery). A Linear section (7-20cm) of the scar will be selected for treatment; Patients will also have to meet other specific criteria. The scar section 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 24hours later. The changes in scar appearance will be measured using colour analysis to assess the change in colour between the Juvista and placebo treated scar segments compared with the surrounding skin. Patients will be assessed for 6 months following treatment.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  08/H0206/61

• Date of REC Opinion

  12 Nov 2008

• REC opinion

  Further Information Favourable Opinion