Stress Impact for Rosacea

No longer recruiting at 1 trial location

Overseen By Thad Wilson, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kristen Metzler-Wilson

Must not be taking: Neural, cardiovascular, muscular drugs

Disqualifiers: Neurological, cardiovascular, respiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stress might affect symptoms of rosacea, a skin condition causing redness and inflammation on the face. Researchers believe the "fight or flight" part of the nervous system could influence these symptoms. Participants will encounter different stressors, such as mental math and local heating, to observe their body's reactions. Individuals with mild to moderate rosacea who are otherwise healthy may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to understanding the link between stress and rosacea, potentially leading to new insights and treatments.

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.

What prior data suggests that these protocols are safe for participants?

Research has shown that stress can significantly affect rosacea symptoms. This trial examines how different stress factors impact the body and rosacea symptoms. Past studies have used activities like mental math and squeezing a handgrip to safely test patient responses to stress. These activities are usually easy to handle and have not caused any serious side effects.

The trial also uses local heating, which involves gently warming the skin. Researchers often use this method in studies, and it is considered safe. The goal is to understand how the body's stress system affects rosacea without introducing any new drugs or chemicals. Participants generally find these stress tests safe and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different stress factors might impact rosacea, a skin condition typically managed with topical creams, oral antibiotics, and laser therapies. Unlike standard treatments that directly target skin symptoms, this trial investigates the body's autonomic responses to stress through mental math and physical exercises, systemic stressors, and localized heating. By understanding how these stressors affect rosacea, researchers hope to uncover new insights into managing the condition, potentially leading to innovative ways to prevent flare-ups by addressing underlying stress responses.

What evidence suggests that this trial's treatments could be effective for rosacea?

Research has shown that rosacea, a skin condition causing redness and swelling, is linked to stress. People with rosacea often experience higher levels of anxiety and depression compared to those without the condition. This connection suggests that stress might worsen rosacea symptoms, possibly through the body's "fight or flight" response. In one study of 138 people with rosacea, many reported a negative impact on their quality of life, supporting the link between stress and rosacea. The trial will explore autonomic responses to stressors, including mental math, handgrip exercise, systemic stressors, end-organ receptor stimulation, and local heating. These findings suggest that managing stress could help reduce rosacea symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Kristen Metzler-Wilson, PT, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Systemic and Local Stressors

Trial Overview The 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.

How Is the Trial Designed?

Group I: Autonomic responses to stressors Experimental Treatment 1 Intervention

Protocol 1: mental math and handgrip exercise. Protocol 2: systemic stressors and end-organ receptor stimulation. Protocol 3: local heating.

Who Is Running the Clinical Trial?

Kristen Metzler-Wilson

Lead Sponsor

Trials

1

Recruited

210+

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Marian University

Collaborator

Trials

1

Recruited

210+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

A study involving 138 patients with rosacea found that the average quality of life score (DLQI) was 14.09, indicating a significant negative impact of the condition on daily living and well-being.

The research highlighted that factors such as age, gender, employment status, and coping strategies, particularly the use of social support, are strongly linked to the quality of life in rosacea patients, suggesting that tailored support could improve their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AND DISEASE COPING STRATEGIES IN PATIENTS WITH ROSACEA. Azrumelashvili, S., Kituashvili, T.[2023]

A study involving 69 patients (43 women and 26 men) identified key triggering factors for rosacea, with stress (58%), sun exposure (56.5%), and alcohol (33.3%) being the most commonly reported.

The findings suggest that understanding and avoiding these triggers, particularly sun exposure, could significantly improve treatment outcomes for rosacea, highlighting the importance of patient awareness and motivation in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aggravating factors of rosacea]. Jaworek, AK., Wojas-Pelc, A., Pastuszczak, M.[2016]

The study found that patients with rosacea exhibit increased sympathetic nerve activity during mental and physical stress, suggesting that their condition may be linked to heightened sympathetic responses to triggers.

Rosacea patients also showed greater transepithelial water loss and a faster onset of sweating and blood flow changes during heat stress, indicating a unique physiological response to environmental triggers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented supraorbital skin sympathetic nerve activity responses to symptom trigger events in rosacea patients. Metzler-Wilson, K., Toma, K., Sammons, DL., et al.[2018]

Recent research has revealed that various triggers of rosacea, such as UV radiation and stress, activate Toll-like receptor signaling and lead to an inflammatory response characterized by the production of cytokines and chemokines.

Understanding the cytokine and chemokine network in rosacea opens up potential therapeutic pathways that could help manage this common skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosacea: The cytokine and chemokine network. Gerber, PA., Buhren, BA., Steinhoff, M., et al.[2022]

Patients with rosacea experience significantly lower life satisfaction and higher levels of anxiety and depression compared to individuals without skin lesions, based on a study involving 40 participants in each group.

The study found that poor social support and higher anxiety and depression levels are key factors that predict life satisfaction in individuals with rosacea, highlighting the psychosocial impact of this skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychosocial impact of rosacea]. Chodkiewicz, J., Salamon, M., Miniszewska, J., et al.[2022]

UVB radiation triggers inflammation in rosacea patients, and the presence of cathelicidin LL-37 significantly enhances this inflammatory response by increasing IL-1β secretion through the P2X7 receptor on keratinocytes.

The study found that LL-37 not only boosts inflammation but also increases the angiogenic potential of endothelial cells, suggesting that it plays a key role in the heightened sensitivity to UV exposure seen in rosacea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cathelicidin peptide LL-37 increases UVB-triggered inflammasome activation: possible implications for rosacea. Salzer, S., Kresse, S., Hirai, Y., et al.[2022]

Azelaic acid 15% gel (Finacea) is a new and effective first-line treatment for mild-to-moderate papulopustular rosacea, showing significant improvement in inflammatory lesions and redness over 15 weeks.

The main action of azelaic acid is its anti-inflammatory effect, which reduces reactive oxygen species, and it has a favorable safety profile with mostly mild side effects that rarely require stopping treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Azelaic acid 15% gel in the treatment of rosacea. Gollnick, H., Layton, A.[2019]

Rosacea is not just a skin condition; it may indicate a chronic systemic inflammatory state and is associated with various systemic diseases.

The pathogenesis of rosacea is still not fully understood, despite known genetic and environmental triggers, highlighting the need for further research into its underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosacea, not just skin deep: Understanding thesystemic disease burden. Morss-Walton, P., McGee, JS.[2021]

A survey of 710 individuals with rosacea identified a high-burden (HB) group of 158 subjects, who reported significantly greater impacts on quality of life and work productivity due to their condition.

Factors such as the severity of rosacea, the effect of health problems on daily activities, and the age at which symptoms first appeared were strongly associated with being classified as high-burden, indicating that these characteristics can help identify patients who may need more intensive management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing high-burden rosacea subjects: a multivariate risk factor analysis from a global survey. Tan, J., Steinhoff, M., Bewley, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10238710/

New Insights into the Mutual Promotion of Rosacea, Anxiety ... Patients with rosacea are at a higher risk of anxiety and depression compared to the healthy population. Compared to skin conditions such as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12497612/

Psychosocial aspects of rosacea: patient-reported coping ... Psychosocial impacts include increased rates of depression, anxiety, social withdrawal, and stigmatization, with evidence that effective ...

3. withpower.com withpower.com/trial/phase-rosacea-4-2019-4f7bc

Stress Impact for Rosacea · Info for Participants A study involving 138 patients with rosacea found that the average quality of life score (DLQI) was 14.09, indicating a significant negative impact of the ...

4. jdermis.com jdermis.com/full-text/the-psychosocial-impact-of-rosacea-how-early-intervention-can-improve-quality-of-life

The Psychosocial Impact of Rosacea: How Early Intervention ... Mild and moderate-to-severe rosacea significantly increase the risk of depression (IRR 1.89-2.04) and anxiety (IRR 1.80-1.98), indicating a dose ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032721013252

Association of rosacea with depression and anxiety Current findings provide more evidence that rosacea is significantly associated with depression and anxiety, and rosacea may predispose patients to develop ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4031723/

Burden of Disease: The Psychosocial Impact of Rosacea on a ... Patients with rosacea have reported a negative burden of their disease, such as low self-esteem, low self-confidence, and decreased social interactions.

7. medicaljournalssweden.se medicaljournalssweden.se/actadv/article/view/40053/46649

Health-related Quality of Life of Patients with Rosacea Rosacea can lead to anxiety, depression, lack of confidence, and low self-esteem, which may exacerbate psychological stress and thereby worsen ...