Vera‐Kellet 2017.
| Trial name or title | Color Doppler Ultrasound Comparison of Topical 10% Nifedipine Versus 5% Sildenafil in Secondary Raynaud: A Randomized, Double‐blind, Placebo‐controlled Pilot Study |
| 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. |
| Participants | 10 patients with clinical diagnosis of secondary Raynaud´s phenomenon associated with a connective tissue disease |
| Interventions | Experimental: 10% nifedipine cream Patient hands (right versus left) were randomized to treatment with topical sildenafil or nifedipine cream. The thumbs of both hands didn't receive any cream so that each subject served as her own control. Subjects were instructed to apply 5 grams of 10% nifedipine cream in one hand and 5 grams of 5% sildenafil cream to the opposite hand. Vinyl gloves were supplied to improve the absorption of the cream into the hand, leaving the thumb of both hands out of the glove without any cream. Active Comparator: 5% sildenafil cream Patient hands (right versus left) were randomized to treatment with topical sildenafil or nifedipine cream. The thumbs of both hands didn't receive any cream so that each subject served as her own control. Subjects were instructed to apply 5 grams of topical10% nifedipine cream in one hand and 5 grams of topical 5% sildenafil cream to the opposite hand. Vinyl gloves were supplied to improve the absorption of the cream into the hand, leaving the thumb of both hands out of the glove without any cream. |
| Outcomes | Primary Outcome Measures: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 [ Time Frame: 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 Secondary Outcome Measures:Improvement of the diameter (mm) of the dorsal arterial arch of the proximal nail fold of the of the index, middle and thumb fingers of both hands. [ Time Frame: 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 diameter is measured with Doppler sonography in millimeters |
| Starting date | August 2016 |
| Contact information | Responsible Party:Pontificia Universidad Catolica de Chile |
| Notes |