NCT03478072

Brief Summary

Autoimmune bullous diseases are a variety of skin diseases that are characterized by the presence of bullae or blisters. Most of these diseases are associated with substantial morbidity and mortality. They are classified according to the site of blister formation into intraepidermal as pemphigus valgaris and foliaceus, and subepidermal as bullous pemphigoid and dermatitis herpetiformis. These lesions commonly affect the scalp and manifest as blisters, erosions and crustations. Trichoscopy (hair and scalp dermoscopy) is a non-invasive technique in which either a handheld dermoscope or a digital videodermoscope can be used to visualize hair and scalp structures. The method has well-established position as an ancillary tool in the diagnosis of many disorders such as, tinea capitis, alopecia areata, androgenetic alopecia, discoid lupus erythematosus, lichen planopilaris, folliculitis decalvans and other hair and scalp diseases. Few studies have reported that immunobullous diseases present characteristic trichoscopic patterns. So, Trichoscopy can be used as a rapid in-office preliminary diagnostic tool in the differential diagnosis of these diseases.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

March 15, 2018

Last Update Submit

July 26, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • trichoscopic features of autoimmune bullous diseases and frequency of each feature.

    Detect trichoscopic features of autoimmune bullous diseases and frequency of each feature.

    1year

  • diagnostic accuracy of trichoscopy in autoimmune bullous diseases.

    detect diagnostic accuracy of trichoscopy in autoimmune bullous diseases..

    1year

Interventions

hair and scalp dermoscopy) is a non-invasive technique in which either a handheld dermoscope or a digital videodermoscope can be used to visualize hair and scalp structures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

upper Egyptian patients

You may qualify if:

  • Patients with clinical \& histopathological diagnosis of autoimmune bullous diseases.

You may not qualify if:

  • Patients who will not consent.
  • Patients with any concomitant dermatological diseases.
  • Pregnancy and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Sar-Pomian M, Rudnicka L, Olszewska M. Trichoscopy - a useful tool in the preliminary differential diagnosis of autoimmune bullous diseases. Int J Dermatol. 2017 Oct;56(10):996-1002. doi: 10.1111/ijd.13725. Epub 2017 Aug 30.

  • Sar-Pomian M, Kurzeja M, Rudnicka L, Olszewska M. The value of trichoscopy in the differential diagnosis of scalp lesions in pemphigus vulgaris and pemphigus foliaceus. An Bras Dermatol. 2014 Nov-Dec;89(6):1007-12. doi: 10.1590/abd1806-4841.20143830.

Study Officials

  • Nagwa Easa, prof

    prof

    STUDY CHAIR

Central Study Contacts

Nagwa Easa, prof

CONTACT

Ayman Mahran, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 27, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

July 30, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share