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Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud

NCT03027674 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-01-23

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

10% nifedipine cream

Topical treatment for Raynaud

DRUG

5% sildenafil cream

Topical treatment for Raynaud

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027674 on ClinicalTrials.gov