Clinical study to assess the safety and efficacy of a new topical formulation of clobetasol 0.05% for mucosal use in patients with mucous membrane pemphigoid

Phase 1

• Conditions: Mucous membrane pemphigoid; MedDRA version: 25.0Level: LLTClassification code 10004296Term: Benign mucous membrane pemphigoid without mention of ocular involvementSystem Organ Class: 100000004858; MedDRA version: 25.0Level: LLTClassification code 10004294Term: Benign mucous membrane pemphigoidSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-001826-23-IT
• Lead Sponsor: Dipartimento di Scienze della Salute dell'Università degli Studi di Firenze

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-25
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

- Male and female from 18 to 90 years old
- Clinical and immunopathological diagnosis of mucous membrane pemphigoid with active lesions on oral mucosa
- Dental hygiene treatment before the beginning of the study
- Stable disease activity: stable immunosuppressive therapy in the last 8 weeks and/or stable systemic steroids therapy (prednisone or comparable steroid) 10 mg/die or lower
- Ability to comprehend all the clinical criteria, to give informed consent and to perform all the clinical procedure
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 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

- Under 18 years of age or over 90
- Modification in immunosuppressive treatments in the last 8 weeks before the beginning of the study
- Treatment with rituximab in the 6 moths before the study
- Hypersesitivity to clobetasol
- Pregnancy of brestfeeding or women planning a pregnancy
- Partecipation to other clinical trial in the 3 moths before the beginning of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified