Clinical trial · Interventional
Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
Analysis of the Efficacy of Two Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
NCT04673916CI-TRIAL-00048927completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study was to compare the therapeutic efficacy of clobetasol propionate 0.05% oral gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lichen Planus, Oral | — | UNRESOLVED | — |
| Preneoplastic Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healing evaluation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clobetasol treatment
- description
- The clobetasol group was treated with clobetasol propionate 0.05%, while the anti-inflammatory group was treated with mouthwash. The drug used consisted of Clobetasol propionate 0.05%, Ethyl alcohol 96° (50%), Hydroxyethylcellulose (4%); Preserved water (just enough to 100%) that was topically applied \[11\]. This drug was produced as a galenic formulation. Clobetasol propionate twice a day (every 12 hours) to the lesions with a soft bristle brush and were advised not to drink or eat during the hour following application of the medication.
- interventionNames
- Drug: Healing evaluation
- type
- ACTIVE_COMPARATOR
- label
- Anti-inflammatory mouthwash
- description
- In patients of the anti-inflammatory group, the mouthwash was used pure and without dilution at a dosage of 20 ml 3 times a day, immediately after normal daily oral hygiene was prescribed. It contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins. Patients were instructed to rinse for at least 5 minutes over the entire oral mucosa, with particular emphasis on the regions where the lesions are located.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years; * clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria; * presence of symptoms related to OLP. Exclusion Criteria: * presence of systemic conditions that may have affected the study results; * state of pregnancy or breastfeeding; * histological signs of dysplasia; * drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.); * treatment of OLP in the six months prior to the start of the programme; * presence of extraoral lesions (genital, skin and other) * history of previous immunodeficiency or HIV seropositivity; * previous allogeneic bone marrow transplantation; * presence of systemic lupus erythematosus or other autoimmune diseases.
References
Publications (1)
- DERIVEDSantonocito S, Polizzi A, De Pasquale R, Ronsivalle V, Lo Giudice A, Isola G. Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Dec 23;18(1):56. doi: 10.3390/ijerph18010056. PMID 33374791