Pemphigus VulgarisAIBDNCT02753777
Autoimmune Blistering Diseases Study
An observational study of Pemphigus Vulgaris and Pemphigus Foliaceus, run by University of Pennsylvania at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus Vulgaris, Pemphigus Foliaceus, Bullous Pemphigoid
- What is being tested?
- Questionnaires
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2016to 2 Jan 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients over the age of 18 who have been diagnosed with pemphigus vulgaris, pemphigus foliaceus or bullous pemphigoid.
Who may be able to join
- Gender/Age: Males or females above 18 years old
- Diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid
- Subjects able to give informed consent
Who cannot join
- Patients who are under age 18 years.
- Patients without pemphigus or pemphigoid diseases
- Penn employees
- Penn students
- Cognitively impaired persons
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Hospital of the University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, 19104
Victoria P Werth, MD, 215-615-2940, werth@pennmedicine.upenn.edu
Joyce Okawa, RN, 215-615-2940, joyce.okawa@pennmedicine.upenn.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Victoria P Werth, MD, 215-615-2940, werth@pennmedicine.upenn.edu
- Recruiting
University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, 19104
Victoria P Werth, MD, 215-615-2940, werth@pennmedicine.upenn.edu
Victoria P. Werth, MD
About this study
Official title: Prevalence and Clinical Severity of Autoimmune Blistering Diseases
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.
Read the detailed description
The disease severity instruments for pemphigus and BP, the Pemphigus Disease Area Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI), respectively, have the potential to capture changes in all grades of disease activity, including mild disease, and therefore represent a substantial improvement over simple lesion counts or measurements of affected body surface area. However, full validation of the PDAI and BPDAI for use in clinical trials will require additional and more extensive measurements that will enable us to classify patients correctly by disease severity and be able to define the minimal change in score that is clinically significant.
This database study will compare the Pemphigus Disease Area and Severity Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI) against other disease severity measures, including the Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and a physician's global assessment. Additionally, patients will be asked to rate their overall disease severity using a visual analogue scale, the patient's global assessment. Participants will also have the option to donate blood samples to our AIBD blood bank for immunologic and pathophysiologic studies.
The purpose of this database study will also be to evaluate quality of life (QoL) measures and correlate these QoL measures with disease severity in patients with pemphigus and BP. QoL is an important and independent component of disease impact on patients. This database study will use the following QoL measures: the SF-36, which is a nonspecific QoL measure; the Skindez-29 and the Dermatology Life Quality Index (DLQI), which are dermatology-specific instruments; the Autoimmune Bullous Disease Quality of Life (ABQOL) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaires, which are AIBD-specific tools. The results will be utilized in planning future clinical studies.
The AIBD study will be conducted only at Penn at this time. Data from the study will be entered into a password protected, web-based database that is used only at Penn.
- Conditions
- Pemphigus Vulgaris, Pemphigus Foliaceus, Bullous Pemphigoid
- Being tested
- Questionnaires
- Medical subject headings
- Pemphigus, Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Pemphigus Disease Area Index (PDAI)
Measured: one year
Bullous Pemphigoid Disease Area Index (BPDAI)
Measured: one year
Secondary outcomes (3)
Autoimmune Bullous Disease Quality of Life (ABQOL)
Measured: one year
Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL)
Measured: one year
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion2 Jan 2030 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Werth, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753777
- Sponsor's protocol ID
- 824790
- Acronym
- AIBD
- Status last verified
- Mar 2026
- First submitted
- 20 Apr 2016
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Severity of Autoimmune Blistering Diseases
- ClinicalTrials.gov ID
- NCT02753777
- Acronym / sponsor ID
- AIBD / 824790
- Conditions
- Pemphigus Vulgaris, Pemphigus Foliaceus, Bullous Pemphigoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 2 Jan 2030 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- 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.
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.
Detailed description
The disease severity instruments for pemphigus and BP, the Pemphigus Disease Area Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI), respectively, have the potential to capture changes in all grades of disease activity, including mild disease, and therefore represent a substantial improvement over simple lesion counts or measurements of affected body surface area. However, full validation of the PDAI and BPDAI for use in clinical trials will require additional and more extensive measurements that will enable us to classify patients correctly by disease severity and be able to define the minimal change in score that is clinically significant.
This database study will compare the Pemphigus Disease Area and Severity Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI) against other disease severity measures, including the Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and a physician's global assessment. Additionally, patients will be asked to rate their overall disease severity using a visual analogue scale, the patient's global assessment. Participants will also have the option to donate blood samples to our AIBD blood bank for immunologic and pathophysiologic studies.
The purpose of this database study will also be to evaluate quality of life (QoL) measures and correlate these QoL measures with disease severity in patients with pemphigus and BP. QoL is an important and independent component of disease impact on patients. This database study will use the following QoL measures: the SF-36, which is a nonspecific QoL measure; the Skindez-29 and the Dermatology Life Quality Index (DLQI), which are dermatology-specific instruments; the Autoimmune Bullous Disease Quality of Life (ABQOL) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaires, which are AIBD-specific tools. The results will be utilized in planning future clinical studies.
The AIBD study will be conducted only at Penn at this time. Data from the study will be entered into a password protected, web-based database that is used only at Penn.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients over the age of 18 who have been diagnosed with pemphigus vulgaris, pemphigus foliaceus or bullous pemphigoid.
Key inclusion criteria (3 listed)
- Gender/Age: Males or females above 18 years old
- Diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid
- Subjects able to give informed consent
Key exclusion criteria (5 listed)
- Patients who are under age 18 years.
- Patients without pemphigus or pemphigoid diseases
- Penn employees
- Penn students
- Cognitively impaired persons
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 |
|---|---|---|
| Questionnaires | Other | – |
Primary outcome
Pemphigus Disease Area Index (PDAI)
Time frame: one year
Bullous Pemphigoid Disease Area Index (BPDAI)
Time frame: one year
3 secondary outcomes
Autoimmune Bullous Disease Quality of Life (ABQOL)
Time frame: one year
Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL)
Time frame: one year
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Time frame: one year
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 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigus Vulgaris and Pemphigus Foliaceus, run by University of Pennsylvania at 3 sites in United States.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Victoria P Werth, MD (215-615-2940, werth@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pemphigus Disease Area Index (PDAI) (time frame: one year). The study lists 2 primary outcomes in all. 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 2026.