NCT03320798

Brief Summary

Bullous pemphigoid affects mainly elderly patients. It is often associated with neurologic disorders, which represent a major risk factor of the disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

October 23, 2017

Last Update Submit

October 23, 2017

Conditions

Keywords

Bullous pemphigoidneurologic disorders

Outcome Measures

Primary Outcomes (1)

  • neurological disease

    neurological disease are dementia (Alzheimers disease or other dementia), Parkinson's syndrome and stroke. Diagnosis of dementia was carried out in several ways: after examination by a neurologist or geriatrician, when the Mini Mental State was less than or equal to 17 or in the presence of a demonstrated and clinically evident dementia.

    Day 0

Study Arms (1)

group "Bullous pemphigoid"

Patients consulting at dermatology department of Reims Teaching Hospital for bullous pemphigoid between 1997 and 2011.

Other: Data record

Interventions

group "Bullous pemphigoid"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting bullous pemphigoid and consulting at dermatology department of Reims Teaching Hospital (France) between 1997 and 2011.

You may qualify if:

  • patients presenting bullous pemphigoid using the following criteria: clinical features typical of BP with presence of at least three out of four well-established criteria of Vaillant et al., subepidermal blister on skin biopsy and deposits of IgG and/or C3 in a linear pattern along the epidermal basement membrane zone by direct IF
  • patients consulting at dermatology department of Reims Teaching Hospital (France) between 1997 and 2011

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Pemphigoid, BullousNervous System Diseases

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 25, 2017

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations