Autoimmune Blistering Diseases Study

NCT02753777 | Recruiting

• 1 other identifier: 824790
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will require the availability of validated disease severity measures that can be used to define primary outcomes.

Conditions

Pemphigus Foliaceus; Bullous Pemphigoid; Pemphigus Vulgaris

Outcome Measures

Primary Outcomes (2)

• Pemphigus Disease Area Index (PDAI)

  one year

• Bullous Pemphigoid Disease Area Index (BPDAI)

  one year

Secondary Outcomes (3)

• Autoimmune Bullous Disease Quality of Life (ABQOL)

  one year

• Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL)

  one year

• Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)

  one year

Interventions

Questionnaires OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients over the age of 18 who have been diagnosed with pemphigus vulgaris, pemphigus foliaceus or bullous pemphigoid.

You may qualify if:

• Gender/Age: Males or females above 18 years old
• Diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid
• Subjects able to give informed consent

You may not qualify if:

• Patients who are under age 18 years.
• Patients without pemphigus or pemphigoid diseases
• Penn employees
• Penn students
• Cognitively impaired persons

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (3)

Hospital of the University of Pennsylvania, Department of Dermatology

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania, Department of Dermatology

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be collected during regularly scheduled clinic visits. The specimens will be processed and stored at the research labs belonging to the principal investigator at the University of Pennsylvania and the Philadelphia VA Medical Center. The specimens will not be publicly available and will be coded and stored in a locked facility equipped with a freezer.

MeSH Terms

Conditions

Pemphigus; Pemphigoid, Bullous

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Victoria P Werth, MD

CONTACT

215-615-2940; werth@pennmedicine.upenn.edu

Joyce Okawa, RN

CONTACT

215-615-2960; Joyce.Okawa@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion (Estimated): January 2, 2030
• Study Completion (Estimated): January 2, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)