Hypothalamus-Pituitary-Adrenal Axis function in the topical management with clobetasol propionate of oral lichen planus (OLP - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010357-12-IT

Enrollment

Registered

2009-03-05

Start date

2009-03-16

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

oral lichen planus MedDRA version: 9.1 Level: LLT Classification code 10030983 Term: Oral lichen planus

Interventions

Trade Name: CLOBESOL*UNG DERM 30G 0,5MG/G Pharmaceutical Form: Ointment INN or Proposed INN: Clobetasol Concentration unit: g gram(s) Concentration type: equal Concentration number: 1-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

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