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

Sponsor:

Information provided by (Responsible Party):

Pontificia Universidad Catolica de Chile

Study Description

Brief Summary:

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
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

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Study Design

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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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Raynaud phenomenon

Drug Information available for: Nifedipine Sildenafil Sildenafil citrate

Genetic and Rare Diseases Information Center resources: Dermatomyositis Systemic Scleroderma Polymyositis Idiopathic Inflammatory Myopathy

U.S. FDA Resources

Arms and Interventions

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

Arm

Intervention/treatment

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.

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.

Drug: 5% sildenafil cream

Topical treatment for Raynaud

Other Name: Topical treatment for Raynaud

Outcome Measures

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

Eligibility Criteria

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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

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Chile
Department of Dermatology, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Santiago, RM, Chile, 7820436

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile

Investigators

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Principal Investigator:	Cristian Vera-Kellet, MD	Connective Tissue Diseases Unit, Department of Dermatology Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.

More Information

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Responsible Party:	Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:	NCT03027674 History of Changes
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

Keywords provided by Pontificia Universidad Catolica de Chile:


Raynaud Phenomena System; Sclerosis Lupus Erythematosus, Systemic	Ultrasound sildenafil Nifedipine

Additional relevant MeSH terms:

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Dermatomyositis Raynaud Disease Lupus Erythematosus, Systemic Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Pathologic Processes Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases	Nervous System Diseases Skin Diseases Peripheral Vascular Diseases Vascular Diseases Cardiovascular 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

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