Topical Amlodipine in Raynaud's Phenomenon - Version 1

• Research type

  Research Study

• Full title

  Digital blood flow response to topical amlodipine in primary Raynaud's phenomenon and systemic sclerosis.

• IRAS ID

  33538

• Contact name

  Marina E Anderson

• Sponsor organisation

  Pharmarama International Limited

• Eudract number

  2009-018194-31

• Research summary

  Does topical amlodipine maleate gel increase blood flow in the fingers of patients with primary Raynaud's phenomenon (PRP) and Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc)?RP is a troublesome condition, affecting approximately 5% of the general population, in which blood flow is prevented from reaching the extremities of the body on exposure to the cold or emotion. The resultant episodic colour changes, numbness and pain of the fingers/toes/nose/ears/lips/tongue can be disabling. Furthermore, severe RP can cause damage to the peripheral tissues. Effective therapies for PRP and the RP of SSc are limited. Calcium channel blockers are the most frequently prescribed medication to ameliorate this condition. However, systemic side-effects of calcium channel blockers limit their use, in practice, in RP. The use of topical preparations to open up the blood vessels in the peripheral tissues and prevent/lessen severity of RP attacks is an attractive mode of therapy because these topical treatments will exert their effects directly at the site of application whilst, due to low circulating concentrations of drug, avoiding systemic side-effects. This research aims to study the effect of applying a novel amlodipine (calcium channel blocker) gel to the fingers of patients who suffer from PRP and RP with SSc. The study will be conducted at University Hospital Aintree, Liverpool. The participants will be acclimatised in a temperature-controlled room at 23 degrees Centigrade for 20 minutes. The skin blood flow of the three middle fingers of the non-dominant hand will be measured using a scanning laser Doppler imager (LDI). Then amlodipine gel will be rubbed on one finger and placebo ointment rubbed on an adjacent finger. LDI will be used to measure the blood flow in the three middle fingers of the hand being studied after ointment application. The whole process would last no more than 3 hours.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/75

• Date of REC Opinion

  3 Nov 2010

• REC opinion

  Further Information Favourable Opinion