Role of the Sympathetic Nervous System in Rosacea

Not Applicable

Recruiting

• Conditions: Rosacea
• Interventions: Other: systemic and local stressors

• Registration Number: NCT03989492
• Lead Sponsor: Indiana University

Brief Summary

Rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. This project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-05-24
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Otherwise healthy males and non-pregnant/non-lactating females with mild to moderate erythematotelangiectactic rosacea, as well as age-sex matched healthy control subjects.

Read More

Exclusion Criteria

• Neurological, cardiovascular, respiratory, metabolic, muscular, or other dermatological disorders
• Current history of alcohol and/or drug abuse
• Known allergies or hypersensitivities to medications/drugs that are used in the protocol
• Current smoking or regular smoking within the last 2 years
• Body mass index > 35 kg/m2
• Medications or supplements which are known to affect neural, cardiovascular, or muscular responses

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autonomic responses to stressors	systemic and local stressors	Protocol 1: mental math and handgrip exercise. Protocol 2: systemic stressors and end-organ receptor stimulation. Protocol 3: local heating.

Primary Outcome Measures

Name	Time	Method
Skin sympathetic nerve activity	Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.	microneurography
Skin blood flow	Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.	laser Doppler flowmetry

Trial Locations

Locations (2)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States