Clinical Trials Register

Summary
EudraCT Number:	2017-000791-29
Sponsor's Protocol Code Number:	CICLO-LPO
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-06-09
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-000791-29

A.3

Full title of the trial

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.

Estudio aleatorizado, intraindividual, doble ciego, controlado con placebo para valorar la eficacia y seguridad de un gel muco-adhesivo de ciclosporina a dos concentraciones diferentes en el tratamiento tópico del liquen plano en mucosa oral.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.4.1

Sponsor's protocol code number

CICLO-LPO

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Clínica Universidad de Navarra/Universidad de Navarra
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Carlos III
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clínica Universidad de Navarra
B.5.2	Functional name of contact point	UCEC
B.5.3	Address:
B.5.3.1	Street Address	Avd. Pio XII 36
B.5.3.2	Town/ city	Pamplona
B.5.3.3	Post code	31008
B.5.3.4	Country	Spain
B.5.4	Telephone number	349482554002725
B.5.5	Fax number	34948296667
B.5.6	E-mail	ucicec@unav.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ciclosporina
D.3.4	Pharmaceutical form	Oromucosal paste
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Buccal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ciclosporin
D.3.9.1	CAS number	59865-13-3
D.3.9.2	Current sponsor code	Mucolast+CsA
D.3.9.3	Other descriptive name	CICLOSPORIN A
D.3.9.4	EV Substance Code	SUB129839
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.5 to 2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oromucosal paste
D.8.4	Route of administration of the placebo	Buccal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

oral lichen planus

liquen plano en mucosa oral

E.1.1.1

Medical condition in easily understood language

oral lichen planus

liquen plano en mucosa oral

E.1.1.2

Therapeutic area

Diseases [C] - Mouth and tooth diseases [C07]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10030983
E.1.2	Term	Oral lichen planus
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Evaluar la eficacia de dos concentraciones (Ciclosporina A al 0.5% y al 2%) diferentes de ciclosporina tópica en un gel muco-adhesivo, en el tratamiento tópico durante 6 semanas del liquen de mucosa oral.

E.2.2

Secondary objectives of the trial

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.

1. Demostrar diferencias en la eficacia de cada una de las dos concentraciones utilizadas.
2. Cuantificar la persistencia de la mejoría tras la suspensión del tratamiento.
3. Valorar la calidad de vida y la satisfacción del paciente tras el tratamiento.
4. Valorar la tolerancia y la seguridad de los tratamientos empleados.

E.2.3

Trial contains a sub-study

E.3

Principal 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).

1. Pacientes diagnosticados de Liquen de mucosas, variante reticular o erosiva. Lesiones en mucosa oral, con una afectación simétrica mínima de 2 cm2. Diagnóstico clínico. Se entiende por mucosa oral la mucosa yugal, la lengua, la mucosa de las arcadas dentales (encías) y la mucosa labial. Se considera afectación simétrica, una imagen en espejo a partir de la línea media lingual.
2. El paciente deberá tener igual o más de 18 años de edad.
3. El paciente, o su representante, ha otorgado su consentimiento para participar en el estudio.
4. El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
5. Confirmación histológica mediante biopsia (con un tiempo de validez de biopsia previa de hasta 2 años si no ha habido cambios clínicos sugestivos de cambio diagnóstico).

E.4

Principal 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.

1. Liquen erosivo con antecedente de carcinoma espinocelular, atipia o displasia.
2. Mujeres embarazadas o lactantes.
3. Enfermedad grave concomitante (proceso oncológico)
4. Incumplimiento de los criterios de tratamiento previo o concomitante.

E.5 End points

E.5.1

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.

Un único evaluador (ciego para el tratamiento) valorará la extensión de la mucosa afecta según la escala siguiente:
• Lesiones reticulares (0 = ninguna; 1 = presencia de estrías blancas)
• Lesiones erosivas (área en cm2).
• Lesiones ulceradas (área en cm2).
Se realizará mediante el análisis de las fotografías e imágenes codificadas.

E.5.1.1

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.

Las evaluaciones se realizarán por un especialista sin conocer el tipo de tratamiento recibido en visitas basal, a durante las semanas 2, 4 y 6.

E.5.2

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).

El paciente valorará los síntomas mediante un cuestionario específico de calidad de vida (versión española validada Skindex 29) en la visita de tratamiento (V2) y a las 6 semanas (V6) y una escala de valoración de la satisfacción a las 4 semanas (V5) y a las 6 semanas (V6).

E.5.2.1

Timepoint(s) of evaluation of this end point

weeks 2, 4, and 6

semanas 2, 4 y 6

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

Última visita último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-22

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-10-01

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