Prevascar in African-Caribbean Scarring

• Research type

  Research Study

• Full title

  An exploratory, single centre, randomized, placebo controlled, assessor blind clinical trial to assess the effects of intradermal administrations of Prevascar on scarring in human subjects of African Continental Ancestral origin

• IRAS ID

  46208

• Contact name

  James Bush

• Sponsor organisation

  Renovo

• Eudract number

  2009-017400-91

• Research summary

  There is considerable variation in scarring both within and between people, and between different ethnic groups. It is recognised that individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. Renovo has conducted studies which demonstrate differences between the skin of individuals of African-Caribbean ancestry and Caucasian ancestry. Renovo has carried out histological comparative investigations of Caucasian and African-Caribbean skin following injury, which has demonstrated histological differences between the two skin types, and provided objective evidence of scars in subjects of African-Caribbean ancestry being wider than those of Caucasian ancestry. Prevascar is being developed as a potential treatment for reducing scarring, and contains Ilodecakin, a recombinant homologue of human Interleukin-1? (IL-10). IL10 is a naturally occurring polypeptide that plays a major role in regulating the inflammatory response. Renovo??s histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of African Caribbean ancestry. The mechanism by which the wound and scar widens is likely to result from the increased inflammatory cell infiltrate at the wound site producing skin remodelling enzymes in excess, resulting in the invasion of the normal dermis by scar tissue. It is likely that this heightened inflammatory response contributes to the progressive wound and scar widening. Previous studies investigating the effects of IL-10 in Caucasians have shown that it reduces scarring. it is hypothesised that IL-10 may be a potentially benefical therapy for the reduction of scarring in Non Caucasians of African-Caribbean ancestry. This clinical trial will be carried out to establish the effects of Prevascar on incisional and excisional scars in subjects of African Continental Group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected Prevascar.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/19

• Date of REC Opinion

  9 Apr 2010

• REC opinion

  Further Information Favourable Opinion