Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud

NCT03027674 | Completed Early Phase 1 DMC

• 1 other identifier: 16-234
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (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

  The peak systolic velocity peak is measured with Doppler sonography in centimeters/second

  Outcome measure will be assessed the same day of the study and the data will be presented after the data is analyzed (12 weeks)

Secondary Outcomes (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.

  Outcome measure will be assessed the same day of the study and the data will be presented after the data is analyzed (12 weeks)

Study Arms (2)

10% nifedipine cream

EXPERIMENTAL

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

5% sildenafil cream

ACTIVE COMPARATOR

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

Interventions

10% nifedipine cream DRUG

Topical treatment for Raynaud

Also known as: Topical treatment for Raynaud

10% nifedipine cream

5% sildenafil cream DRUG

Topical treatment for Raynaud

Also known as: Topical treatment for Raynaud

5% sildenafil cream

Eligibility Criteria

• Age: 13 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of secondary Raynaud´s phenomenon associated with a connective tissue disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

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

Santiago, RM, 7820436, Chile

Location

MeSH Terms

Conditions

Raynaud Disease; Scleroderma, Diffuse; Lupus Erythematosus, Systemic; Dermatomyositis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Cristian Vera-Kellet, MD

  Connective Tissue Diseases Unit, Department of Dermatology Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: August 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)