Stress Impact for Rosacea

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

210 Participants Needed

Trial Summary

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?

Azelaic acid 15% gel, also known as Finacea, is considered a safe treatment for mild-to-moderate rosacea, with most side effects being mild or temporary and not usually requiring stopping the treatment. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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.

Research Team

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.

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

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Georgia (Republic) pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AND DISEASE COPING STRATEGIES IN PATIENTS WITH ROSACEA. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Azelaic acid 15% gel in the treatment of rosacea. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Characterizing high-burden rosacea subjects: a multivariate risk factor analysis from a global survey. [2020]

4. Poland pubmed.ncbi.nlm.nih.gov

[Psychosocial impact of rosacea]. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

[Aggravating factors of rosacea]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Augmented supraorbital skin sympathetic nerve activity responses to symptom trigger events in rosacea patients. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Rosacea: The cytokine and chemokine network. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Rosacea, not just skin deep: Understanding thesystemic disease burden. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cathelicidin peptide LL-37 increases UVB-triggered inflammasome activation: possible implications for rosacea. [2022]