NCT03926377

Brief Summary

Bullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. The treatment of this pathology consists of the application of high doses of topical corticosteroids (clobetasol propionate) for a prolonged period of at least 6 months. The main objective of this study is to demonstrate a change in bone mineral density at 6 months after initiation of treatment, in subjects with bullous pemphigoid and treated with topical corticosteroid.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4.5 years

First QC Date

April 15, 2019

Last Update Submit

April 11, 2023

Conditions

OsteoporosisBullous Pemphigoid

Keywords

osteoporosisdermocortocoidsbullous pemphigoidpharmacoepidemiology

Outcome Measures

Primary Outcomes (1)

  • Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment.

    Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the initiation of the treatment and at 6 months (theoretical end of the treatment).

    6 months after beginning of the treatment

Secondary Outcomes (6)

  • Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment of attack.

    3 months after beginning of the treatment

  • Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment of attack.

    3 months after beginning of the treatment

  • Variation of the bone mineral density (BMD) expressed in g/cm² at the hip between baseline and the theorical end of the treatment.

    6 months after beginning of the treatment

  • Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment of attack.

    3 months after beginning of the treatment

  • Variation in plasma concentrations of corrected calcemia, phosphoremia, 25 OH vitamin D and cortisolemia between Baseline and the theorical end of the treatment.

    6 months after beginning of the treatment

  • +1 more secondary outcomes

Study Arms (1)

Clobetasol propionate treatment

OTHER

Clobetasol propionate (Dermoval® 0,5% cream), administered for 6 months.

Procedure: bone densitometryBiological: blood testProcedure: radiographs of the thoracic and lumbar spineProcedure: Clobetasol propionate

Interventions

bone densitometryPROCEDURE

Patients with bullous pemphigoid will benefit from bone densitometry at the initiation of treatment, at 3 months (theoretical end of the treatment of attack) and at 6 months (theoretical end of the treatment).

Clobetasol propionate treatment
blood testBIOLOGICAL

Blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 hours to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 hours cortisolemia.

Clobetasol propionate treatment
radiographs of the thoracic and lumbar spinePROCEDURE

standard radiographs of the thoracic and lumbar spine will be done at the initiation of treatment and at 6 months.

Clobetasol propionate treatment
Clobetasol propionatePROCEDURE

Clobetasol propionate (Dermoval® 0,5% cream), administered for 6 months.

Clobetasol propionate treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients presenting a multi-bullous pemphigoid newly diagnosed or relapsed more than 3 months after stopping corticosteroids and treated according to the national protocol for diagnosis and care issued by the reference center for autoimmune bullous diseases of April 2016
  • patients having received written and oral information and signed informed consent
  • patients covered by national health insurance

You may not qualify if:

  • Patients under tutorship or curatorship or inability to give informed consent
  • Patients receiving an anti-osteoporotic treatment
  • Patients requiring an anti-osteoporotic baseline treatment (T-score ⩽ -3DS on at least 1 site or FRAX score above the therapeutic intervention threshold)
  • Patients with one or more major risk factors for osteoporosis
  • Patients who have received topical corticosteroids in less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

OsteoporosisPemphigoid, Bullous

Interventions

Hematologic TestsClobetasol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSkin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Guillaume Chaby, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

  • Catherine Lok, Pr

    CHU Amiens

    PRINCIPAL INVESTIGATOR

  • Pascal Joly, Pr

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Batteux, MD

CONTACT

(33)322088370batteux.benjamin@chu-amiens.fr

Guillaume Chaby, MD

CONTACT

(33)322455846chaby.guillaume@chu-amiens.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 24, 2019

Study Start

April 1, 2019

Primary Completion

October 1, 2023

Study Completion

April 1, 2024

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)