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Telederm and Bullous Pemphigoid

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ClinicalTrials.gov Identifier: NCT04728854
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : June 7, 2022
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Ron Feldman, Emory University

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.

Condition or disease
Bullous Pemphigoid

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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Clinical Trial Recruitment and Outcome Measures in Bullous Pemphigoid
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

Group/Cohort
Adult bullous pemphigoid patients
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.



Primary Outcome Measures :
  1. Change in Bullous pemphigoid disease area index (BPDAI) [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    Change in Bullous pemphigoid disease area index (BPDAI) activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity (worse outcome).


Secondary Outcome Measures :
  1. Change in ItchyQol score [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    ItchyQoL focuses on pruritus as the main symptom impacting quality of life. ItchyQol score is based on an averaged 10-point visual analogue scale (VAS) over three time periods. Lower score correlates with better outcome.

  2. Change in Autoimmune Bullous Disease Quality of Life score (ABQoL) [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    The Autoimmune Bullous Disease Quality of Life (ABQoL) score is a 17 item questionnaire assessing quality of life in patients with autoimmune blistering diseases. It is a patient reported score. Each question ranges from 0 to 3 points, with higher scores indicating poorer quality of life. The maximum ABQOL score is 51.

  3. Change in Treatment of Autoimmune Bullous Disease Quality of Life (TABQoL) score [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    The Treatment of Autoimmune Bullous Disease Quality of Life (TABQoL) score is a patient reported score. The score is a 17 item questionnaire assessing quality of life in patients with autoimmune blistering diseases. Each question ranges from 0 to 3 points, with higher scores indicating poorer quality of life. The maximum TABQOL score is 51.

  4. Change in patient and physician global assessment [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    The Physician and Patient Global Assessments will assess skin related health on a 0-5 scale at each visit. The lower score correlates with disease improvement (better outcome).

  5. Number of participants with confidence that the dermatologist can help by looking at photos [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    This outcome is part of the patient satisfaction survey regarding teledermatology (TD) visits in order to encourage patient enrollment and retention for the length of the trial. Higher number of patients correlates with better outcome.

  6. Number of participants with confidence that the teledermatology visit is more convenient than going to the dermatology clinic [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    This outcome is part of the patient satisfaction survey regarding teledermatology (TD) visits in order to encourage patient enrollment and retention for the length of the trial. Higher number of patients correlates with better outcome.

  7. Number of participants that believe they will use the teledermatology service again [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    This outcome is part of the patient satisfaction survey regarding teledermatology (TD) visits in order to encourage patient enrollment and retention for the length of the trial. Higher number of patients correlates with better outcome.

  8. Change in teledermatology satisfaction score [ Time Frame: Baseline, monthly post-baseline for 4 months, 6 months post-baseline ]
    Teledermatology satisfaction will be evaluated using a survey that includes 3 questions. Possible score ranges from 0 to 3, with higher score correlating with better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
45 patients from Emory Dermatology Clinic will be enrolled
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728854


Contacts
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Contact: Bridget Bradley, RN 404-778-3084 brbradl@emory.edu

Locations
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United States, Georgia
Emory Dermatology Clinic Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bridget Bradley, RN    404-778-3084    brbradl@emory.edu   
Sponsors and Collaborators
Emory University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Ron Feldman, MD, PhD Emory University
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Responsible Party: Ron Feldman, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT04728854    
Other Study ID Numbers: STUDY00001274
1R01AR076089-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ron Feldman, Emory University:
Bullous Pemphigoid
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases