Juvista in Scar Revision surgery of disfiguring scars.
Research type
Research Study
Full title
A double blind, within patient, placebo controlled trial to assess the efficacy of Juvista (Avotermin) in conjunction with scar revision surgery for the improvement of disfiguring scars.
IRAS ID
4653
Sponsor organisation
Renovo Ltd
Eudract number
2008-002124-28
Clinicaltrials.gov Identifier
Research summary
Each year, over one hundredmillion people undergo elective or emergency surgery and are left withscarring. Of these, over half a million patients undergo scar revision surgery.These types of scars are usually disfiguring, aesthetically unpleasant and cancause complications such as severe itching, tenderness, pain, depression anddisruption of daily activities which can lead to a diminished quality of life.There is a clinical need for treatments that reduce scarring, as currenttherapies are often ineffective or inadequate. Results from previous clinicaltrials show that Juvista is effective in improving scars in young and elderlymales and females. Juvista treated wounds appear to heal with scars that aremore similar to the surrounding skin, and are narrower and paler with a fasterfading of redness compared to placebo and standard care alone. This study willconfirm the effectiveness of Juvista (Avotermin) in the improvement of scarappearance when applied to the wound margins of patients following scarrevision surgery of disfiguring scars. This study is funded by Renovo Ltd andwill recruit patients from 8 European countries including the UK. The studyis a double blind, within patient, placebo controlled, randomised trial in maleand female patients. Patients will be asked to attend 10 study visits and willbe followed up post-surgery for 12 months. The potential benefits to the patientstaking part in the trial will be that their scar is revised by a plasticsurgeon. This procedure should leave subjects with a less noticeable scar. Theexisting scar will be surgically removed and the resulting wound will bedivided into two segments of equal length. In most patients, one segment willreceive treatment with Juvista administered by intradermal injection, the otherwith placebo. A few patients will receive treatment with Juvista to bothsegments of the wound.
REC name
North East - York Research Ethics Committee
REC reference
08/H0903/63
Date of REC Opinion
17 Nov 2008
REC opinion
Further Information Favourable Opinion