Atlanta, Georgia 30322

  • Bullous Pemphigoid

Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT04728854


Primary Contact:

Principal Investigator
Ron Feldman, MD, PhD
Emory University

Bridget Bradley, RN
Phone: 404-778-3084
Email: brbradl@emory.edu


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States

Bridget Bradley, RN
Phone: 404-778-3084
Email: brbradl@emory.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 23, 2021

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