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.

Phase 1

• Conditions: oral lichen planus; MedDRA version: 20.0Level: PTClassification code 10030983Term: Oral lichen planusSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2017-000791-29-ES
• Lead Sponsor: Clínica Universidad de Navarra/Universidad de Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-09
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified