CHU Amiens
Amiens, 80480, France
NCT Number: NCT03926377
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Amiens, 80480, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
standard radiographs of the thoracic and lumbar spine will be done at the initiation of treatment and at 6 months.
Clobetasol propionate (Dermoval® 0,5% cream), administered for 6 months.
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).
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).
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).
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).
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).
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).
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).
Centre Hospitalier Universitaire, Amiens
Other
Acronym: DERMOS
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