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Clobetasol propionate 0.05% versus placebo for the management of erosive oral lichen planus

Clobetasol propionate 0.05% versus placebo for the management of erosive oral lichen planus: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10647973
Enrollment
20
Registered
2015-12-08
Start date
2016-01-01
Completion date
Unknown
Last updated
2018-05-21

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

Conditions

Oral lichen planus Skin and Connective Tissue Diseases

Interventions

The study is divided into two phases: phase I consisted of topical treatment for 2 months
phase II was a six-month follow-up period without therapy. Patients are randomly divided into two groups. Randomization is performed using computer-generated random number tables. The first group of p

Sponsors

University of Turin (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histological diagnosis of OLP on the basis of WHO criteria: hyperkeratosis of the superficial epithelial layers, vacuolar degeneration of the germinative layer of the epithelium and band-like sub-epithelial lymphocytic inflammatory infiltrate 2. Presence of painful and atrophic-erosive oral lesions, at the same time with reticular ones 3. Ability to complete the present trial

Exclusion criteria

Exclusion criteria: 1. Presence of histological signs of dysplasia 2. Use of lichenoid reaction inducing drugs and presence of amalgam fillings close to lesions 3. Therapy for OLP in the 2 months prior to the study 4. Pregnant or breastfeeding women 5. Proved or suspected hypersensitivity caused by the tested chemicals

Design outcomes

Primary

MeasureTime frame
Pain (visual analogue scale [VAS]) and clinical scores (Thongpranson scale) assessed at baseline, 4 weeks, 8 weeks, 20 weeks and 32 weeks

Secondary

MeasureTime frame
1. Time taken to reduce signs and symptoms during the first two weeks of treatment 2. Length of remission from signs and symptoms

Countries

Italy

Outcome results

None listed

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