Pemphigus DiseaseNCT06901427
Impact of a Lifestyle Program on Quality of Life in Pemphigus Patients
A study testing Mediterranean Diet and exercise in people with Pemphigus Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pemphigus Disease
- What is being tested?
- Mediterranean Diet and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adults aged 18-65 years diagnosed with pemphigus. 2. Willingness and ability to adhere to prescribed lifestyle modifications.
Who cannot join
- 1. Presence of severe comorbidities that could impede adherence to dietary interventions and regular exercise 2. Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pemphigus Disease
- Being tested
- Mediterranean Diet and exercise
- Keywords
- lifestyle, quality of life, pemphigus
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet and exerciseBehavioural
A structured dietary intervention promoting Mediterranean-style eating patterns and regular exercise for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification Program | Experimental | Not described Receives: Behavioral: Mediterranean Diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over a three-month period
Secondary outcomes (1)
Prevalence of pemphigus in Assuit city
Measured: over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start10 May 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHAbdelhafeez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901427
- Sponsor's protocol ID
- Lifestyle in pemphigus
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lifestyle Modification Program on the Quality of Life in Patients with Pemphigus
- ClinicalTrials.gov ID
- NCT06901427
- Acronym / sponsor ID
- Lifestyle in pemphigus
- Conditions
- Pemphigus Disease
- Keywords
- lifestyle, quality of life, pemphigus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification Program | Experimental | Behavioral: Mediterranean Diet and exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adults aged 18-65 years diagnosed with pemphigus. 2. Willingness and ability to adhere to prescribed lifestyle modifications.
Key exclusion criteria (1 listed)
- 1. Presence of severe comorbidities that could impede adherence to dietary interventions and regular exercise 2. Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet and exerciseA structured dietary intervention promoting Mediterranean-style eating patterns and regular exercise for 12 weeks. | Behavioural | Lifestyle Modification Program |
Primary outcome
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
1 secondary outcome
Prevalence of pemphigus in Assuit city
Time frame: over 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet and exercise in people with Pemphigus Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelhafeez hamdi Abdelhafeez (+201002809764, Abdoofiz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.