Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud
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ClinicalTrials.gov Identifier: NCT03027674 |
Recruitment Status :
Completed
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
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Raynaud Phenomenon Due to Trauma Raynaud Disease System; Sclerosis Lupus Erythematosus, Systemic Dermatomyositis Ultrasound Therapy; Complications | Drug: 10% nifedipine cream Drug: 5% sildenafil cream | Early Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | "Color Doppler Ultrasound Comparison of Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud: A Randomized, Double-blind, Placebo-controlled Pilot Study" |
Study Start Date : | August 2016 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
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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.
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Drug: 10% nifedipine cream
Topical treatment for Raynaud
Other Name: Topical treatment for Raynaud |
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.
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Drug: 5% sildenafil cream
Topical treatment for Raynaud
Other Name: Topical treatment for Raynaud |
- 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
- 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

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Ages Eligible for Study: | 13 Years to 99 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of secondary Raynaud´s phenomenon associated with a connective tissue disease
Exclusion Criteria:
- Primary Raynaud´s phenomenon
- Current infection of any digit
- Known allergic reaction to calcium-channel blockers or phosphodiesterase type 5 inhibitor
- Current use of calcium-channel blockers or phosphodiesterase type 5 inhibitors
- Pregnancy
- Hypotension or hypertension
- History of myocardial infarction, stroke, or life-threatening arrhythmia.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027674
Chile | |
Department of Dermatology, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. | |
Santiago, RM, Chile, 7820436 |
Principal Investigator: | Cristian Vera-Kellet, MD | Connective Tissue Diseases Unit, Department of Dermatology Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. |
Responsible Party: | Pontificia Universidad Catolica de Chile |
ClinicalTrials.gov Identifier: | NCT03027674 |
Other Study ID Numbers: |
16-234 |
First Posted: | January 23, 2017 Key Record Dates |
Last Update Posted: | January 23, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Raynaud Phenomena System; Sclerosis Lupus Erythematosus, Systemic |
Ultrasound sildenafil Nifedipine |
Dermatomyositis Raynaud Disease Lupus Erythematosus, Systemic Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Pathologic Processes Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases Skin Diseases |
Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Autoimmune Diseases Immune System Diseases Nifedipine Sildenafil Citrate Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents Calcium Channel Blockers Membrane Transport Modulators |