Telederm and Bullous Pemphigoid

NCT04728854 | Completed

• 2 other identifiers: STUDY000012741R01AR076089-01A1
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid

Keywords

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• Change in Bullous pemphigoid disease area index (BPDAI)

  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).

  Baseline, monthly post-baseline for 4 months, 6 months post-baseline

Secondary Outcomes (8)

• Change in ItchyQol score

  Baseline, monthly post-baseline for 4 months, 6 months post-baseline

• Change in Autoimmune Bullous Disease Quality of Life score (ABQoL)

  Baseline, monthly post-baseline for 4 months, 6 months post-baseline

• Change in Treatment of Autoimmune Bullous Disease Quality of Life (TABQoL) score

  Baseline, monthly post-baseline for 4 months, 6 months post-baseline

• Change in patient and physician global assessment

  Baseline, monthly post-baseline for 4 months, 6 months post-baseline

• Number of participants with confidence that the dermatologist can help by looking at photos

  Baseline, monthly post-baseline for 4 months, 6 months post-baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

45 patients from Emory Dermatology Clinic will be enrolled

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Emory Dermatology Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ron Feldman, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: March 15, 2021
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)