A Rare Disease Cohort of Oral Mucosal Pemphigus

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600129330

Enrollment

Unknown

Registered

2026-08-03

Start date

2026-08-14

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral mucosal pemphigus

Interventions

Patients with pemphigus involving the oral mucosa group :None

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. According to the *Chinese Guidelines for the Diagnosis and Treatment of Pemphigus (2024 Edition)*, a diagnosis of pemphigus can be established as follows: for patients with clinical manifestations and skin histopathology consistent with pemphigus, and who meet at least one of the immunological test criteria, a diagnosis of pemphigus vulgaris or pemphigus foliaceus can be made. In cases where histopathological findings are atypical, but clinical manifestations and direct immunofluorescence (DIF) are consistent, and at least one of indirect immunofluorescence (IIF) or enzyme-linked immunosorbent assay (ELISA) criteria is met, a diagnosis can also be established. 2. The lesions must include involvement of the oral mucosa. 3. Able to truthfully provide epidemiological information. 4. Agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with other concomitant autoimmune diseases. 3. Patients with infectious diseases such as hepatitis C, syphilis, and AIDS.

Design outcomes

Primary

Measure	Time frame
Pemphigus Disease Area Index,PDAI;Characteristics of the oral microbiota obtained by metagenomic sequencing;Cumulative relapse rate;Proportion of patients achieving complete remission after treatment;Environmental factors;	—

Secondary

Measure	Time frame
Oral Health Impact Profile-14,OHIP-14 ;Visual Analogue Scale;anti Dsg1/Dsg3 titers;Cumulative corticosteroid dose per year;Dermatology Life Quality Index (DLQI);Time to achieve minimal therapy;Time to complete remission off systemic therapy;	—

Countries

China

Contacts

Public ContactShen Xuemin

Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine

kiyoshen@163.com+86 21 23271699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026