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Trial record 29 of 143 for:    NIFEDIPINE

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

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

  Show Detailed Description

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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


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




Primary Outcome Measures :
  1. 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 :
  1. 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
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.

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.

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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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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
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Calcium Channel Blockers
Membrane Transport Modulators