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

A prospective, non controlled, phase 2 pilot 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 - Topical clobetasol for patients with mucous membrane pemphigoid

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001826-23-IT

Enrollment

Registered

2022-10-25

Start date

2023-05-31

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucous membrane pemphigoid MedDRA version: 25.0 Level: LLT Classification code 10004296 Term: Benign mucous membrane pemphigoid without mention of ocular involvement System Organ Class: 100000004858 MedDRA version: 25.0 Level: LLT Classification code 10004294 Term: Benign mucous membrane pemphigoid System Organ Class: 100000004858

Interventions

Product Name: clobetasolo propionato Product Code: [clobetasolo propionato] Pharmaceutical Form: Oromucosal gel CAS Number: 25122-46-7 Current Sponsor code: clobetasolo propionato Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the safety of a 0.05% clobetasol topical formulation (number, entity, severity and nature of possible side effects);Secondary Objective: Evaluation of tolerability (patients compliance, number of patients who complete the course of therapy) and response to treatment (reduction of clinical objective and subjective score of disease activity);Primary end point(s): Evaluation of the safety of the product (number, entity, severity and nature of possible side effects whit CTCAE scale);Timepoint(s) of evaluation of this end point: From the beginning to the end of the study	—

Measure

Time frame

Main Objective: Evaluation of the safety of a 0.05% clobetasol topical formulation (number, entity, severity and nature of possible side effects);Secondary Objective: Evaluation of tolerability (patients compliance, number of patients who complete the course of therapy) and response to treatment (reduction of clinical objective and subjective score of disease activity);Primary end point(s): Evaluation of the safety of the product (number, entity, severity and nature of possible side effects whit CTCAE scale);Timepoint(s) of evaluation of this end point: From the beginning to the end of the study

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Secondary

Measure	Time frame
Secondary end point(s): Tolerability (number of patients who complete the course of therapy, administration of questionnaires); Change in MMPDAI score in V0, after 30, 60 and 90 days; Change in VAS pain score in V0, after 30, 60 and 90 days; Change of VAS burn score in V0, after 30, 60 and 90 days; Change of DLQUI score in V0, after 30, 60 and 90 days; Improvement of CGIC score; Improvement of PGIC; Days needed to heal oral lesions;Timepoint(s) of evaluation of this end point: From the beginning to the end of the study; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60, day 90; Day 30, 60 and 90; Day 30, 60, 90; Day 30, 60, 90	—

Measure

Time frame

Secondary end point(s): Tolerability (number of patients who complete the course of therapy, administration of questionnaires); Change in MMPDAI score in V0, after 30, 60 and 90 days; Change in VAS pain score in V0, after 30, 60 and 90 days; Change of VAS burn score in V0, after 30, 60 and 90 days; Change of DLQUI score in V0, after 30, 60 and 90 days; Improvement of CGIC score; Improvement of PGIC; Days needed to heal oral lesions;Timepoint(s) of evaluation of this end point: From the beginning to the end of the study; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60, day 90; Day 30, 60 and 90; Day 30, 60, 90; Day 30, 60, 90

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Countries

Italy

Contacts

Public ContactDSS UniFi

Emiliano Antiga

emiliano.antiga@unifi.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026