Telederm and Bullous Pemphigoid

Emory University

Status: Completed

Conditions: Bullous Pemphigoid

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04728854

STUDY00001274

1R01AR076089-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to improve the quality of future clinical trials in bullous pemphigoid (BP), the investigators will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months.

Full description

The study team plans to recruit 45 subjects from the autoimmune blistering disease clinic at Emory Dermatology Clinic. The plan is to improve the quality of future clinical trials in bullous pemphigoid (BP), the team will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months. This time frame will allow completion of both aims in the three year time period. Aim 1 will evaluate the BPDAI scoring over time with specific reductions in the activity score as future outcomes for therapeutic response and assess changes in patient reported outcomes particularly related to pruritus for future clinical trial endpoints. Aim 2 will focus on the development of teledermatology platform for improving patient recruitment and retention. The data from this proposal will be critical for future BP clinical trials and clarify gaps in the current knowledge related to the natural disease history of BP patients on standard-of-care therapies, changes in BPDAI scores over time, and pruritus specific outcome measures to define the quality of life impact.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females > age 18
• Clinical and histological confirmation of bullous pemphigoid including at least subepidermal separation on H&E or a positive direct immunofluorescence along with indirect immunofluorescence which demonstrates staining to the roof on salt split skin or ELISA positivity for BP180 and/or BP230 autoantibodies
• Baseline BPDAI-TAS >5

Exclusion criteria

• Subjects who are unable to consent, language barriers, or other unspecified reason that in the opinion of the investigator makes the subject unsuitable for enrollment. Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.

Trial design

21 participants in 1 patient group

Adult bullous pemphigoid patients

Description:

Patients with diagnosis of bullous pemphigoid will participate in monitoring with face to face assessment and remote telehealth visits with store and forward images captured.