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Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid

NCT03926377 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-13

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

bone densitometry

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).

BIOLOGICAL

blood test

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.

PROCEDURE

radiographs of the thoracic and lumbar spine

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

PROCEDURE

Clobetasol propionate

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

Sponsors & Collaborators

  • University Hospital, Rouen

    collaborator OTHER

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Guillaume Chaby, MD · CHU Amiens

  • Catherine Lok, Pr · CHU Amiens

  • Pascal Joly, Pr · CHU Amiens

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-10-31
Completion
2024-04-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03926377 on ClinicalTrials.gov