NCT06901427

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 23, 2025

Last Update Submit

March 23, 2025

Conditions

Pemphigus Disease

Keywords

lifestyle, quality of life, pemphigus

Outcome Measures

Primary Outcomes (1)

  • 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

    over a three-month period

Secondary Outcomes (1)

  • Prevalence of pemphigus in Assuit city

    over 2 years

Study Arms (1)

Lifestyle Modification Program

EXPERIMENTAL
Behavioral: Mediterranean Diet and exercise

Interventions

Mediterranean Diet and exerciseBEHAVIORAL

A structured dietary intervention promoting Mediterranean-style eating patterns and regular exercise for 12 weeks.

Lifestyle Modification Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pemphigus

Interventions

Diet, MediterraneanExercise

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Abdelhafeez hamdi Abdelhafeez

CONTACT

+201002809764Abdoofiz@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER assistant

Study Record Dates

First Submitted

March 23, 2025

First Posted

March 30, 2025

Study Start

May 10, 2025

Primary Completion

November 20, 2025

Study Completion

December 20, 2025

Last Updated

March 30, 2025

Record last verified: 2025-03