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Clinical Trials/NCT06901427
NCT06901427Not yet recruitingNot Applicable

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

Assiut University0 sites44 target enrollmentStarted: May 10, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
44
Primary Endpoint
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

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Lifestyle Modification Program

Experimental

Intervention: Mediterranean Diet and exercise (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Prevalence of pemphigus in Assuit city(over 2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AHAbdelhafeez

LECTURER assistant

Assiut University

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