Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cyclosporine mucoadhesive gel at two different concentrations in the topical treatment of oral lichen planus in the oral mucosa.

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cyclosporine mucoadhesive gel at two different concentrations in the topical treatment of lichen planus in the oral mucosa.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000791-29-ES

Enrollment

Registered

2017-06-09

Start date

2017-07-13

Completion date

Unknown

Last updated

2018-10-15

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: 20.0 Level: PT Classification code 10030983 Term: Oral lichen planus System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Ciclosporina Pharmaceutical Form: Oromucosal paste INN or Proposed INN: Ciclosporin CAS Number: 59865-13-3 Current Sponsor code: Mucolast+CsA Other descriptive name: CICLOSPORIN A Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with lichen mucosa, reticular or erosive variant. Lesions in oral mucosa, with a symmetric affection minimum of 2 cm2. Clinical diagnosis. The oral mucosa is understood as the oral mucosa, the tongue, the mucosa of the dental arches (gums) and the labial mucosa. A symmetrical affectation is considered a mirror image from the lingual midline. 2. The patient must be at least 18 years of age or older. 3. The patient, or his / her representative, has consented to participate in the study. 4. The patient should, in the opinion of the investigator, be able to meet all the requirements of the clinical trial. 5. Histological confirmation by biopsy (with a biopsy validity time of up to 2 years if there have been no clinical changes suggestive of diagnostic change). 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 23 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Erosive lichen with a history of squamous cell carcinoma, atypia or dysplasia. 2. Pregnant or lactating women. 3. Concomitant severe disease (cancer process) 4. Non-compliance with the criteria for prior or concomitant treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of two different concentrations of cyclosporin A (0.5% and 2%) cyclosporin topical on a mucoadhesive gel in the topical treatment for 6 weeks of oral mucosa lichens.;Secondary Objective: 1. Demonstrate differences in the efficacy of each of the two concentrations used. 2. To quantify the persistence of improvement after discontinuation of treatment. 3. Assess quality of life and patient satisfaction after treatment. 4. Assess the tolerance and safety of the treatments used.;Primary end point(s): An evaluator (blind for treatment) will assess the extent of mucosal involvement according to the following scale: • Reticular lesions (0 = none; 1 = presence of white streaks) • Erosive lesions (area in cm2). • Ulcerated lesions (area in cm2). It will be done by analyzing the coded photographs and images.;Timepoint(s) of evaluation of this end point: Evaluations will be performed by a specialist without knowing the type of treatment received at baseline visits, at weeks 2, 4 and 6.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of two different concentrations of cyclosporin A (0.5% and 2%) cyclosporin topical on a mucoadhesive gel in the topical treatment for 6 weeks of oral mucosa lichens.;Secondary Objective: 1. Demonstrate differences in the efficacy of each of the two concentrations used. 2. To quantify the persistence of improvement after discontinuation of treatment. 3. Assess quality of life and patient satisfaction after treatment. 4. Assess the tolerance and safety of the treatments used.;Primary end point(s): An evaluator (blind for treatment) will assess the extent of mucosal involvement according to the following scale: • Reticular lesions (0 = none; 1 = presence of white streaks) • Erosive lesions (area in cm2). • Ulcerated lesions (area in cm2). It will be done by analyzing the coded photographs and images.;Timepoint(s) of evaluation of this end point: Evaluations will be performed by a specialist without knowing the type of treatment received at baseline visits, at weeks 2, 4 and 6.

—

Secondary

Measure	Time frame
Secondary end point(s): The patient will assess the symptoms through a specific quality of life questionnaire (Spanish version validated Skindex 29) at the treatment visit (V2) and at 6 weeks (V6) and a satisfaction assessment scale at 4 weeks (V5) and at 6 weeks (V6).;Timepoint(s) of evaluation of this end point: weeks 2, 4, and 6	—

Countries

Spain

Contacts

Public ContactUCEC

Clínica Universidad de Navarra

ucicec@unav.es349482554002725

Outcome results

None listed

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