Clinical trial NCT04728854: Telederm and Bullous Pemphigoid
Official title: Improving Clinical Trial Recruitment and Outcome Measures in Bullous Pemphigoid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Pemphigoid
Keywords: Bullous Pemphigoid
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-01-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 patients from Emory Dermatology Clinic will be enrolled

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in Bullous pemphigoid disease area index (BPDAI)
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Secondary outcomes:
measure: Change in ItchyQol score
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
measure: Change in Autoimmune Bullous Disease Quality of Life score (ABQoL)
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
measure: Change in Treatment of Autoimmune Bullous Disease Quality of Life (TABQoL) score
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
measure: Change in patient and physician global assessment
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
measure: Number of participants with confidence that the dermatologist can help by looking at photos
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
measure: Number of participants with confidence that the teledermatology visit is more convenient than going to the dermatology clinic
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
measure: Number of participants that believe they will use the teledermatology service again
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
measure: Change in teledermatology satisfaction score
timeFrame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Dermatology Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Ron Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: