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Completed

NCT Number: NCT04728854

Telederm and Bullous Pemphigoid

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.

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Key information

Conditions

Bullous Pemphigoid Autoimmune Diseases Immune System Diseases Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory Dermatology Clinic

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Improving Clinical Trial Recruitment and Outcome Measures in Bullous Pemphigoid

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2021
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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