Study to investigate the efficacy and safety of M518101 in psoriasis
Research type
Research Study
Full title
A randomised, placebo-controlled, double-blind, left-right comparison, multi-centre phase IIa study to investigate the efficacy and safety of M518101 in plaque psoriasis patients
IRAS ID
20355
Contact name
Jonathan NWN Barker
Eudract number
2009-010805-35
Clinicaltrials.gov Identifier
Research summary
Psoriasis is a chronic, non-contagious autoimmune disease which affects the skin and joints. It commonly causes red scaly patches to appear on the skin. The scaly patches caused by psoriasis are called psoriatic plaques which are areas of inflammation and excessive skin production. The purpose of this trial is to test a new drug to treat psoriasis called M518101 which is similar to a vitamin D3 preparation. Vitamin D3 is routinely used in treating psoriasis however, a side effect from using the vitamin is a rise in calcium levels in the serum and urine. The study drug is provided in the form of an ointment, which would have a stronger effect in healing psoriatic plaques and lead to fewer side effects compared to vitamin D3 preparations. Maruho Co., Ltd is sponsoring a study to collect information on M518101. Adult psoriasis patients will be randomly assigned to three different doses of M518101 compared to a vitamin D3 ointment already on the market and placebo (an ointment that looks like M518101 ointment but does not contain any active drug substance). This is a randomised, placebo-controlled, double-blind study meaning either the patient nor the study doctor will know which medication is being given. This is a multicentre study which will take place across Europe across approximately 25 study centres. It is anticipated that 144 patients will be taking part, 7 of those in the UK.
REC name
London - London Bridge Research Ethics Committee
REC reference
09/H0804/59
Date of REC Opinion
6 Aug 2009
REC opinion
Further Information Favourable Opinion