Clinical Trials Register

Summary
EudraCT Number:	2019-002285-12
Sponsor's Protocol Code Number:	OJ-KDC01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-10-21
Trial 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

2019-002285-12

A.3

Full title of the trial

An exploratory, multicenter, randomized, open-label with blind evaluation, active-controlled study to evaluate the safety and efficacy of Keramod
(imiquimod 50 mg/g, Gel) compared with Aldara (imiquimod 50 mg/g, Cream) for the treatment of actinic keratosis in adults

Estudio exploratorio, aleatorizado, abierto con evaluación ciega, multicéntrico, controlado con control activo, para evaluar la eficacia y seguridad de la aplicación tópica de KERAMOD (gel de imiquimod 50 mg/g) frente Aldara (crema de imiquimod 50 mg/g) en el tratamiento de queratosis actínica (QA) en adultos.

A.3.1

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

Keramod Gel vs Aldara for the treatment of actinic keratosis

Keramod Gel vs Aldara en el tratamiento de la queratosis actínica

A.4.1

Sponsor's protocol code number

OJ-KDC01

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	LABORATORIO OJER PHARMA, S.L.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	LABORATORIO OJER PHARMA, S.L.
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	LABORATORIO OJER PHARMA, S.L.
B.5.2	Functional name of contact point	PATRICIA OJER
B.5.3	Address:
B.5.3.1	Street Address	CALLE SANCHO EL MAYOR, Nº2 1ºIZQ
B.5.3.2	Town/ city	PAMPLONA
B.5.3.3	Post code	31002
B.5.3.4	Country	Spain
B.5.4	Telephone number	34948281776
B.5.5	Fax number	34948287859
B.5.6	E-mail	pojer@ojerpharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
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	KERAMOD
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IMIQUIMOD
D.3.9.1	CAS number	99011-02-6
D.3.9.2	Current sponsor code	IMIQUIMOD
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB12453MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	No
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.IMP: 2
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	Yes
D.2.1.1.1	Trade name	ALDARA
D.2.1.1.2	Name of the Marketing Authorisation holder	Meda AB
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IMIQUIMOD
D.3.9.1	CAS number	99011-02-6
D.3.9.2	Current sponsor code	IMIQUIMOD
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB12453MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

ACTINIC QUERATOSIS, also known as solar keratosis, is a skin disease caused by chronic exposure to sunlight. It appears as scaly lesions on the skin as a result of an abnormal growth of the cells in the most outer layer of the epidermis. There may be a single lesion or multiple lesions, and they are usually found on areas of the skin that are regularly exposed to the sun, such as the face, neck, hands, forearms and scalp.

QUERATOSIS ACTÍNICA, Conocida también como queratosis solar, La queratosis actínica es un parche grueso y escamoso en la piel, que se desarrolla después de muchos años de exposición al sol. Comúnmente se encuentra en el rostro, cuello, el dorso de las manos, los antebrazos y el cuero cabelludo.

E.1.1.1

Medical condition in easily understood language

ACTINIC QUERATOSIS, also known as solar keratosis, is a skin disease caused by chronic exposure to sunlight.

QUERATOSIS ACTÍNICA, Conocida también como queratosis solar, La queratosis actínica es un parche grueso y escamoso en la piel, que se desarrolla después de muchos años de exposición al sol.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

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 Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream), in the treatment of AK in terms of complete clearance of AK lesions at week 24 since the first treatment dose.

Evaluar la eficacia de Keramod® Gel (imiquimod al 5 %, gel) frente a Aldara® Crema (imiquimod al 5 %, crema) en el tratamiento de la queratosis actínica (QA) en términos de eliminación completa de las lesiones de la QA 24 semanas después de la primera dosis del tratamiento

E.2.2

Secondary objectives of the trial

• To evaluate the reduction in the number of AK lesions from baseline to weeks 8 and 16 in subjects treated with Keramod® Gel versus Aldara® Cream.
• To evaluate the efficacy of Keramod® Gel (imiquimod 5%, Gel) versus Aldara® Cream (imiquimod 5%, cream).
• To evaluate the safety of the topical treatment of Keramod® Gel versus Aldara® Cream.
• To evaluate the treatment tolerance and patient acceptance of the treatment in subjects treated with Keramod® Gel versus Aldara® Cream.
• To evaluate quality of life in subjects treated with Keramod® Gelm versus Aldara® Cream.

- Evaluar la redución de lesiones desde la visita la visita basal hasta la semana 8 y semana 16 de tratamiento en pacientes tratados con Keramod Gel frente a Aldara
- Evaluar la eficacia de Keramod Gel frente Aldara en función de las lesiones eliminadas en la semana 8 y la semana 16
- Evaluar la seguridad del tratamiento con Keramod Gel frente a Aldara
- Evaluar la tolarancia y aceptación del tratamiento con Keramod Gel frente a Aldara
- Evaluar la Calidad de Vida en los pacientes tratados con Keramod frente a los tratados con Aldara

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or balding scalp.

Presencia de entre 4 y 8 lesiones de QA diagnosticadas clínicamente, no hiperqueratósicas y no hipertróficas, en una zona de tratamiento contigua de 25 cm2 en el cuero cabelludo parcialmente sin pelo o en la cara.

E.4

Principal exclusion criteria

Basal cell or squamous cell carcinoma, or other possible confounding skin conditions (on face and scalp), in the treatment area.

Presencia, en la zona de tratamiento (cara o cuero cabelludo), de carcinoma de células basales o escamosas u otros trastornos cutáneos que puedan inducir a confusión.

E.5 End points

E.5.1

Primary end point(s)

Complete clearance of AK lesions, defined as a count of zero AK lesions at week 24 since the first treatment dose.

Eliminación completa de las lesiones de la AQ, lo que se define como un recuento cero de lesiones de QA en la semana 24, a contar desde la primera dosis del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

Time Frame: 8 weeks post-treatment (Week 24, Test of Cure/ TOC, visit 6)

Período de tiempo: 8 semanas después del tratamiento (semana 24, Test of Cure (TOC), visita 6)

E.5.2

Secondary end point(s)

• Partial clearance rate of AK lesions at the end of first treatment cycle: proportion of subjects with at least a 75% reduction in the number of AK lesions counted at baseline.
• Complete clearance rate of AK lesions at the end of first treatment cycle: proportion of subjects with a count of zero AK lesions
• Tolerance and acceptability of the treatment by the study subject assessed by the Treatment tolerance and satisfaction questionnaire
• Quality of life assessed by the Actinic Keratosis Quality of Life Questionnaire
• Rate of subjects who complete one treatment cycle
• Severity and frequency of associated adverse events/serious adverse events (AEs/SAEs)

- Eliminación parcial de las lesiones de QA
- Eliminación Completa de las lesiones de QA
- Tolerancia y Aceptación del tratamiento
- Evaluación de la Calidad de Vida
- Ratio de pacientes que completan 1 ciclo de tratamiento
- Ratio de pacientes que completan 2 ciclos de tratamiento
- Gravedad y Frecuencia de los AEs/SAEs

E.5.2.1

Timepoint(s) of evaluation of this end point

• Partial and Complete clearance rate of AK lesions at the end of first and second cycles.: Week 8 (end of first cycle treatment period; visit 3) and Week 16 (end of second cycle treatment period; visit 5).
• Tolerance and acceptability: Visits 2, 3, 4, 5 & 6.
• Quality of life assessed: Week 24; Visit 6.
• Rate of subjects who complete one and two treatment cycles: Week 8; Visit 3 and Week 16; Visit 5.
• Severity and frequency of associated adverse events/serious adverse events: Week 24.

- Eliminación parcial de las lesiones de QA: Semana 8 (Visita 3) y Semana 16 (Visita 5)
- Eliminación Completa de las lesiones de QA: Semana 8 (Visita 3) y Semana 16 (Visita 5)
- Tolerancia y Aceptación del tratamiento: Visitas 2, 3, 4, 5 & 6
- Evaluación de la Calidad de Vida: Semana 24 (Visita 6)
- Ratio de pacientes que completan 1 ciclo de tratamiento: Semana 8 (Visita 3)
- Ratio de pacientes que completan 2 ciclos de tratamiento: Semana 16 (Visita 5)
- Gravedad y Frecuencia de los AEs/SAEs: Week 24

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

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

ALDARA

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

End of Study (Visit 6): All subjects will attend to a post-treatment visit that will be in 8 weeks after the last administration of the study treatment (Visit 6, day 169).
The procedures scheduled for this visit may be carried out within 4 days of the scheduled visit (i.e. Day 169 ± 4 days).

Fin de estudio (Visita 6): Todos los pacientes asistirán a esta visita planeada 8 semanas después de la última dosis. (Visita 6, dia 169).
Los procedimientos de esta visita se pueden realizar con una ventana de 4 dias (Dia 169 +/- 4 días).

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

2019-12-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-28

P. End of Trial
P.	End of Trial Status	Ongoing

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