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

April 11, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Glucocorticoids have direct effects on bone remodeling by suppressing bone formation (inhibition of osteoblastic differentiation, inhibition of mature osteoblasts function and apoptosis of mature osteoblasts) and by increasing bone resorption (decrease in osteoclast apoptosis and stimulation of osteoclastogenesis). They also have indirect bone effects by decreasing the intestinal absorption of calcium and increasing its urinary excretion, and by inhibiting the somatotropic and gonadotropic axis. This pathophysiology results in excessive bone fragility. Bone loss and increased incidence of fractures occur within 6 months after the introduction of oral corticosteroid therapy, with a partially reversible phenomenon within months of discontinuation. The extent of bone loss depends on the dose and duration of glucocorticoid administration.

The systemic transition of topical corticosteroids depends on several parameters such as excipients, anatomical location, cutaneous state, the dose used and the duration of exposure.

Clobetasol propionate, used for long-term use in bullous pemphigoid, is a Class IV dermocorticoid (highly potent). 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).

Patients will also benefit a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 cortisolemia (braking of the hypothalamic-pituitary-adrenal axis).

Patients will also benefit from standard radiographs of the thoracic and lumbar spine at the initiation of treatment and at 6 months. Follow-up is planned over 6 months, with 2 follow-up visits at 3 months and 6 months.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clobetasol propionate treatment
Clobetasol propionate (Dermoval® 0,5% cream), administered for 6 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of the bone mineral density (BMD) expressed in g/cm² at the lumbar spine between baseline and the theorical end of the treatment.
Time Frame: 6 months after beginning 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months after beginning 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 3 months (theoretical 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.
Time Frame: 3 months after beginning of the treatment
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the hip at the initiation of the treatment and at 3 months (theoretical 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.
Time Frame: 6 months after beginning of the treatment
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from bone densitometry at the hip at the initiation of the treatment and at 6 months (theoretical 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.
Time Frame: 3 months after beginning of the treatment
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8h at the initiation of the treatment and at 3 months (theoretical end of the treatment 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.
Time Frame: 6 months after beginning of the treatment
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from a blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8h at the initiation of the treatment and at 6 months (theoretical end of the treatment).
6 months after beginning of the treatment
frequency of fractures (axial and , or peripheral)
Time Frame: 6 months after beginning of the treatment
Patients with bullous pemphigoid and treated with Clobetasol propionate will benefit from standard radiographs of the thoracic and lumbar spine at the initiation of the treatment and at 6 months (theoretical end of the treatment).
6 months after beginning of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

University Hospital, Rouen

Investigators

  • Principal Investigator: Catherine Lok, Pr, CHU Amiens
  • Principal Investigator: Guillaume Chaby, MD, CHU Amiens
  • Principal Investigator: Pascal Joly, Pr, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2018_843_0040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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