Stress Impact for Rosacea
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kristen Metzler-Wilson
Must not be taking: Neural, cardiovascular, muscular drugs
Disqualifiers: Neurological, cardiovascular, respiratory, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications or supplements that affect neural, cardiovascular, or muscular responses.
Is azelaic acid 15% gel safe for treating rosacea?
How does the treatment for stress impact in rosacea differ from other treatments?
This treatment is unique because it focuses on the role of stress and sympathetic nerve activity in triggering rosacea symptoms, which is different from traditional treatments that primarily target inflammation or skin symptoms directly. By addressing the stress-related mechanisms, it may offer a novel approach to managing rosacea.16789
Research Team
KM
Kristen Metzler-Wilson, PT, PhD
Principal Investigator
University of Kentucky
Eligibility Criteria
This trial is for healthy males and females with mild to moderate rosacea, who are not pregnant or breastfeeding. Participants should not have any major health issues like heart or neurological disorders, no recent drug/alcohol abuse, no allergies to protocol drugs, non-smokers, and a BMI under 35.Inclusion Criteria
I am healthy, not pregnant, and have mild to moderate rosacea.
Exclusion Criteria
You weigh too much for this study.
I am not taking any medications or supplements that affect my nerves, heart, or muscles.
You currently have a history of alcohol or drug abuse.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Experimental Protocol
Participants undergo mental math, handgrip exercise, systemic stressors, end-organ receptor stimulation, and local heating to assess autonomic responses
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the experimental protocol
1-2 weeks
Treatment Details
Interventions
- Systemic and Local Stressors (Behavioural Intervention)
Trial OverviewThe study investigates how stressors affecting the 'fight or flight' nervous system contribute to rosacea symptoms. It aims to improve understanding of this relationship in order to develop better treatments for those suffering from rosacea.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Autonomic responses to stressorsExperimental Treatment1 Intervention
Protocol 1: mental math and handgrip exercise. Protocol 2: systemic stressors and end-organ receptor stimulation. Protocol 3: local heating.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of KentuckyLexington, KY
Loading ...
Who Is Running the Clinical Trial?
Kristen Metzler-Wilson
Lead Sponsor
Trials
1
Patients Recruited
210+
Indiana University
Lead Sponsor
Trials
1063
Patients Recruited
1,182,000+
Marian University
Collaborator
Trials
1
Patients Recruited
210+
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Trials
508
Patients Recruited
1,090,000+
References
QUALITY OF LIFE AND DISEASE COPING STRATEGIES IN PATIENTS WITH ROSACEA. [2023]Rosacea is a chronic, inflammatory skin disorder that adversely affects patients' life quality. The aim of the study was to evaluate the quality of life (QoL) and to find the connection between QoL and coping strategies in the patients suffering from rosacea. A total of 138 patients, aged from 22 to 80, took part in this research with the first-time confirmed diagnosis of rosacea. All patients completed the Dermatology Life Quality Index (DLQI) questionnaire in order to evaluate the patients' attitudes to the impact of rosacea on QoL and Coping Strategies Questionnaires (COPE). The study has determined that Average DLQI in the case of rosacea equals 14.09+3.18. Mean Rosacea-Specific DLQI is symptoms and feelings - 3.75+1.92, daily activities - 3.12+1.77; leisure - 2.52+1.81, work and/or school - 1.52+1.50, personal relationships - 2.42+1.90, treatment - 1.59+1.04. The usage of instrumental social support - 3.39 has the highest score factor in the COPE questionnaire. Rosacea has a strong impact on human life. QoL in rosacea patients is connected to such factors as age, gender, employment status, self-esteem, and subtype of the disease. Correlation analysis shows the connection between the quality of life and coping strategy. Based on the recession analysis formula, the large and extremely large effect of DLQI can be calculated according to the existing risk consequently, the results obtained in our study may be a kind of starting point for the elaboration of complex support for patients with rosacea.
Azelaic acid 15% gel in the treatment of rosacea. [2019]Rosacea represents a chronic inflammatory dermatosis of uncertain pathophysiology. There are several associated risk factors and the need for long-term treatment is well recognized. This diverse disease is frequently difficult to manage and has a significant impact on quality of life. There are several topical and oral treatments available, of which azelaic acid 15% gel (Finacea) is the first new treatment for rosacea in more than a decade. Azelaic acid per se has multiple modes of action in rosacea, but an anti-inflammatory effect achieved by reducing reactive oxygen species appears to be the main pharmacological action. Clinical studies have shown that azelaic acid 15% gel is an effective and safe first-line topical therapeutic option in patients with mild-to-moderate papulopustular rosacea. Significant continuous improvement in the number of inflammatory lesions and in erythema has been shown over a period of 15 weeks. Adverse effects associated with azelaic acid 15% gel are mostly mild or transient and do not usually necessitate discontinuation of therapy.
Characterizing high-burden rosacea subjects: a multivariate risk factor analysis from a global survey. [2020]Objective: To characterize rosacea features suitable for identification of high-burden (HB) subjects in clinical practice.Design: Global online survey with subjects recruited using an online panel from the United States, Canada, Italy, United Kingdom, Germany and France. Subjects self-reported a physician's diagnosis of rosacea.Measurements: HB subjects were defined as those with ≥3/4 domains (quality of life, lifestyle adaptation, time trade-off, willingness to pay) greater than the median. Group characteristics were analyzed and multivariate-logistic modeling used to investigate factors most associated with HB.Results: 710 subjects completed the survey, including 158 HB subjects. HB was observed in all self-declared rosacea severities. HB subjects were more likely to spend more time daily on skin care and experienced approximately double the impact of health problems on work productivity in the past 7 days (p < .01). In the past 12 months, HB subjects were more likely to have at least one visit to the emergency room (41.8% vs 11.2%; p < .01). In the multivariate risk analysis, factors most associated with HB included rosacea severity, impact of health problems on regular daily activities and age at first symptoms.Conclusion: Rosacea has a distinct subset of HB subjects who can be successfully characterized.
[Psychosocial impact of rosacea]. [2022]Rosacea is a common skin disease. Because of its recurrent character, frequent unsatisfying results of treatment and a cosmetic problem, the skin lesions cause negative patients' psychosocial functioning. The purpose of this study was to evaluate life satisfaction, social support, general health, anxiety and depression level in people with rosacea. An attempt to select conditions which determine the life satisfaction in these patients was also made. 40 people with rosacea and 40 people with no skin lesions were the subjects of the study. It was demonstrated that in comparison to the control group, patients with rosacea are less satisfied with their lives, subjectively feel that they receive poor social support, develop great intensity of symptoms, have difficulty in functioning in everyday life, worse general health perception, along with a higher level of anxiety and depression. Level of anxiety and depression as well as social integration proved to be the predictors of life satisfaction.
[Aggravating factors of rosacea]. [2016]Rosacea is a chronic, inflammatory skin disease which is mainly localized in the central region of the face. Papules and pustules appear on the erythematic ground. Rosacea is common in population. Four subtypes of rosacea (erythematoteleangiectatic rosacea, ETR; papulo - pustular rosacea, PPR; ocular rosacea and phymatous rosacea) are classified (according to current classification) and one variant rosacea (granulomatous rosacea, GR). It is considered that an attempt to determine of triggering factors of rosacea should be the first step to treatment. Then it should be tried to eliminate contact with them. The aim of this study was an analysis of triggering factors of rosacea. 43 women and 26 men treated in the Dermatology Outpatient's Clinic of Jagiellonian University School of Medicine in Cracow were enrolled in the study. All patients were asked which factors trigger skin changes according to them. Patients mentioned most often: stress (58 percent), sun exposure (56.5 per. cent), alcohol (33.3 percent), exercise (29 percent), drinking coffee (21.7 percent) and hot meals (20.3 percent). They regarded the sun as the most strongly aggravating factor of rosacea (29.2 percent). It seems, that elimination and reduction of contact with aggravating factors is still an undervalued aspect of rosacea's treatment. Patients' motivation for use of prevention seems to be also very important. Knowledge about aggravating factors of rosacea, coming directly from patients' observations, may help in more effective treatment.
Augmented supraorbital skin sympathetic nerve activity responses to symptom trigger events in rosacea patients. [2018]Facial flushing in rosacea is often induced by trigger events. However, trigger causation mechanisms are currently unclear. This study tested the central hypothesis that rosacea causes sympathetic and axon reflex-mediated alterations resulting in trigger-induced symptomatology. Twenty rosacea patients and age/sex-matched controls participated in one or a combination of symptom triggering stressors. In protocol 1, forehead skin sympathetic nerve activity (SSNA; supraorbital microneurography) was measured during sympathoexcitatory mental (2-min serial subtraction of novel numbers) and physical (2-min isometric handgrip) stress. In protocol 2, forehead skin blood flow (laser-Doppler flowmetry) and transepithelial water loss/sweat rate (capacitance hygrometry) were measured during sympathoexcitatory heat stress (whole body heating by perfusing 50°C water through a tube-lined suit). In protocol 3, cheek, forehead, forearm, and palm skin blood flow were measured during nonpainful local heating to induce axon reflex vasodilation. Heart rate (HR) and mean arterial pressure (MAP) were recorded via finger photoplethysmography to calculate cutaneous vascular conductance (CVC; flux·100/MAP). Higher patient transepithelial water loss was observed (rosacea 0.20 ± 0.02 vs. control 0.10 ± 0.01 mg·cm(-2)·min(-1), P
Rosacea: The cytokine and chemokine network. [2022]Rosacea is one of the most common dermatoses of adults. Recent studies have improved our understanding of the pathophysiology of rosacea. Current concepts suggest that known clinical trigger factors of rosacea such as UV radiation, heat, cold, stress, spicy food, and microbes modulate Toll-like receptor signaling, induce reactive oxygen species, as well as enhance antimicrobial peptide and neuropeptide production. Downstream of these events cytokines and chemokines orchestrate an inflammatory response that leads to the recruitment and activation of distinct leukocyte subsets and induces the characteristic histopathological features of rosacea. Here we summarize the current knowledge of the cytokine and chemokine network in rosacea and propose pathways that may be of therapeutic interest.
Rosacea, not just skin deep: Understanding thesystemic disease burden. [2021]Rosacea is a common inflammatory skin condition with four main clinical subtypes: erythematotelangiectatic, papulopustular, rhinophymatous, and ocular. Although several genetic and environmental factors have been linked with triggering rosacea, the pathogenesis still remains poorly understood. There is an increasing evidence in the literature to support that rosacea is a harbinger of several systemic comorbidities and may represent a chronic, systemic, inflammatory state. We have provided the most up-to-date evidence on the association between rosacea and several systemic diseases, discussing that rosacea is not just a skin disorder but a systemic disease process.
Cathelicidin peptide LL-37 increases UVB-triggered inflammasome activation: possible implications for rosacea. [2022]In patients with rosacea, environmental stressors, especially UVB radiation, trigger disease flares that are characterized by inflammation and vascular hyperactivity. An altered innate immune detection and response system, modulated to a large extent by the aberrant production and processing of human cathelicidin LL-37, is thought to play a central role in disease pathogenesis.