Hypothalamus-Pituitary-Adrenal Axis function in the topical management with clobetasol propionate of oral lichen planus (OLP - ND
- Conditions
- oral lichen planusMedDRA version: 9.1Level: LLTClassification code 10030983Term: Oral lichen planus
- Registration Number
- EUCTR2009-010357-12-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Clinical presence of atrophic/erosive lesions of oral mucosa due to OLP;
Histological diagnosis of oral lichen planus;
Age > 18 years;
Presence of painful lesions due to OLP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Presence of histological signs of dysplasia;
Use of lichenoid reaction-inducing drugs;
Contemporaneous skin or genital lichenoid lesions;
Previous pharmacological therapy for OLP;
Treatment with systemic glucocorticoids 6 months before the study;
Presence of diseases which have effect on adrenal function.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the hypothalamus-pituitary-adrenal-axis function in the chronic treatment with clobetasol propionate;Secondary Objective: Efficacy;Primary end point(s): nd
- Secondary Outcome Measures
Name Time Method