"Color Doppler Ultrasound Comparison of Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud: A Randomized, Double-blind, Placebo-controlled Pilot Study"

NCT03027674 EARLY_PHASE1 COMPLETED

Objective: To compare the efficacy of topical 10% nifedipine versus 5% sildenafil in patients with secondary Raynaud's phenomenon (RP). Methods: A randomized, double-blind, placebo-controlled pilot study took place in 10 patients with secondary RP. Topical 10% nifedipine on one hand and 5% sildenafil on the other hand were applied. The thumbs didn't receive any cream and served as a control group. The primary outcome was the improvement of blood flow and vessel diameter of the digital arteries measured by high frequency color Doppler ultrasound before and 1 hour after treatment.

Details

Lead sponsor	Pontificia Universidad Catolica de Chile
Phase	EARLY_PHASE1
Status	COMPLETED
Enrolment	10
Start date	2016-08
Completion	2016-08

Conditions

• Raynaud Phenomenon Due to Trauma
• Raynaud Disease
• System; Sclerosis
• Lupus Erythematosus, Systemic
• Dermatomyositis
• Ultrasound Therapy; Complications

Interventions

• 10% nifedipine cream
• 5% sildenafil cream

Primary outcomes

• Improvement of blood flow in the digital arteries (peak systolic velocity ) of the dorsal arterial arch of the proximal nail fold of the index, middle and thumb fingers of both hands — Outcome measure will be assessed the same day of the study and the data will be presented after the data is analyzed (12 weeks)
  The peak systolic velocity peak is measured with Doppler sonography in centimeters/second

Countries

Chile