Impact of a Lifestyle Program on Quality of Life in Pemphigus Patients

March 23, 2025 updated by: AHAbdelhafeez, Assiut University

Effectiveness of Lifestyle Modification Program on the Quality of Life in Patients with Pemphigus

The aim of this study is To evaluate the impact of lifestyle modifications, including dietary changes and regular exercise, on skin-related quality of life in patients with pemphigus by assessing changes in Skindex-16 scores over a three-month period.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The skin, the body's largest organ, serves as a critical protective barrier against environmental hazards and plays a pivotal role in immune defence.

Autoimmune diseases arise when the immune system erroneously targets the body's own tissues, leading to chronic inflammation and tissue damage. Globally, the prevalence of these disorders is on the rise, significantly impacting patient morbidity and healthcare systems.

Pemphigus is a rare autoimmune blistering disorder characterized by the production of autoantibodies against desmogleins-proteins essential for cell-to-cell adhesion within the epidermis.

Epidemiologically, pemphigus vulgaris (PV) is the most common subtype, with incidence rates varying geographically. Higher incidences are observed in regions such as the Middle East, with Iran reporting up to 5 cases per 100,000 people annually. In the Arab world, PV predominates in countries like Egypt, Sudan, and Morocco.

Complications of pemphigus are multifaceted. Patients are susceptible to secondary bacterial, viral, and fungal infections due to compromised skin integrity, which can escalate to sepsis. Oral mucosal involvement often leads to painful erosions, causing difficulties in alimentation and subsequent nutritional deficiencies.

The psychological burden of pemphigus is considerable. Chronic pain, visible lesions, and social stigma contribute to elevated rates of anxiety and depression among patients. Studies indicate that approximately 30.7% of individuals with pemphigus experience anxiety or depressive disorders, underscoring the need for comprehensive psychosocial support in this population.

Therapeutically, systemic corticosteroids remain the cornerstone of pemphigus management, often supplemented with immunosuppressants and biologic agents like rituximab. While effective, these treatments carry risks; long-term corticosteroid use is associated with adverse effects such as osteoporosis, increased infection risk, and metabolic disturbances.

Despite advancements in therapeutic strategies, there remains a paucity of research focusing on lifestyle modifications as adjunctive measures in managing pemphigus. This study aims to explore the potential benefits of integrating lifestyle interventions to enhance patient outcomes, reduce treatment-related complications, and improve overall quality of life.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abdelhafeez hamdi Abdelhafeez
  • Phone Number: +201002809764
  • Email: Abdoofiz@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Adults aged 18-65 years diagnosed with pemphigus. 2. Willingness and ability to adhere to prescribed lifestyle modifications.

Exclusion Criteria:

  • 1. Presence of severe comorbidities that could impede adherence to dietary interventions and regular exercise 2. Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Modification Program
Behavioral: Mediterranean Diet and exercise
A structured dietary intervention promoting Mediterranean-style eating patterns and regular exercise for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation the impact of lifestyle modifications, including dietary changes and regular exercise, on skin-related quality of life in patients with pemphigus by assessing changes in Skindex-16 scores over a three-month period
Time Frame: over a three-month period
over a three-month period

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of pemphigus in Assuit city
Time Frame: over 2 years
over 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2025

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lifestyle in pemphigus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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