Clinical Trials Register

Summary
EudraCT Number:	2015-002540-13
Sponsor's Protocol Code Number:	RD.06.SPR.18252
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-10-30
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

2015-002540-13

A.3

Full title of the trial

A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris

Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para comparar la eficacia y seguridad de la crema CD5789 50 µg/g frente a la crema placebo en sujetos con acné vulgar.

A.3.1

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

A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris

A.3.2

Name or abbreviated title of the trial where available

Double-Blind Efficacy and Safety of CD5789 50µg/g Cream versus Vehicle Cream in Acne Vulgaris

A.4.1

Sponsor's protocol code number

RD.06.SPR.18252

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/231/2014

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Galderma R&D SNC
B.1.3.4	Country	France
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	Galderma R&D
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Chiltern International Spain S.A.
B.5.2	Functional name of contact point	Ricardo Diaz (General Director)
B.5.3	Address:
B.5.3.1	Street Address	Centro Empresarial Euronova 3, Ronda de Poniente 10 ? 2ª Planta
B.5.3.2	Town/ city	Tres Cantos, Madrid
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491187 27 00
B.5.5	Fax number	+3491187 28 49
B.5.6	E-mail	spain.regulatory@chiltern.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.3.2	Product code	CD5789
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	Yes
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	Trifarotene
D.3.9.1	CAS number	895542-09-3
D.3.9.2	Current sponsor code	CD5789
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50.000
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cream
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acne Vulgaris

Acné vulgar

E.1.1.1

Medical condition in easily understood language

Acne

Acné

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10000519
E.1.2	Term	Acne vulgaris
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks in subjects with moderate facial and truncal acne vulgaris.

Los objetivos del ensayo clínico son evaluar la eficacia y la seguridad de la crema CD5789 50µg/g aplicada una vez al día durante 12 semanas en sujetos con acné vulgar de leve a moderado en la cara y en el tronco.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, 9 years of age and older, at the Screening visit.
2. The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline.
3. The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline.
4. The subject has truncal acne severity grade of 3 (moderate) on the Physician Global assessment (PGA) scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of study drug by the subject (optional criterion for subject between 9 and 11 years of age).

1. El sujeto es un hombre o una mujer de 9 años en adelante en la visita de selección.
2. El sujeto presenta acné facial con un grado de intensidad 3 (moderado) según la escala de evaluación global del investigador (Investigator Global Assessment, IGA) en la visita de selección y de inicio.
3. El sujeto presenta un mínimo de 20 lesiones inflamatorias y 25 lesiones no inflamatorias en la cara en la visita de selección y de inicio.
4. El sujeto presenta acné en el tronco con un grado de intensidad 3 (moderado) según la escala de evaluación global del médico (Physician Global Assessment, PGA) en las visitas de selección y de inicio en partes del tronco (hombros, parte superior de la espalda y parte superior anterior del pecho), a las que el propio sujeto pueda llegar para aplicarse el fármaco del estudio (criterio opcional para sujetos entre 9 y 11 años de edad).

E.4

Principal exclusion criteria

1. The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
2. The subject has more than 1 nodule on the face at Screening and Baseline.
3. The subject has more than 1 nodule on the trunk at Screening and Baseline
4. The subject has any acne cysts on the trunk at Screening and at Baseline.

1. El sujeto presenta formas graves de acné (p. ej., acné conglobata, acné fulminante) o forma de acné secundaria (p. ej., cloracné, acné inducido por fármacos, etc.).
2. El sujeto presenta más de 1 nódulo en la cara en la visita de selección y de inicio.
3. El sujeto presenta más de 1 nódulo en el tronco en la visita de selección y de inicio.
4. El sujeto presenta algún quiste de acné en la cara en la visita de selección y de inicio.

E.5 End points

E.5.1

Primary end point(s)

1) Success Rate, defined as the percentage of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement
2) Absolute Change in facial non-inflammatory lesion count.
3) Absolute Change in facial inflammatory lesion count

1) Tasa de éxito, definida como el porcentaje de sujetos que alcanzaron una puntuación en la IGA de 1 (Casi remisión) o 0 (Remisión) y al menos una mejoría de 2 grados desde el inicio hasta la semana 12.
2) Cambio absoluto en el número de lesiones no inflamatorias faciales desde el inicio hasta la semana 12.
3) Cambio absoluto en el número de lesiones inflamatorias faciales.

E.5.1.1

Timepoint(s) of evaluation of this end point

1) from Baseline to Week 12
2) from Baseline to Week 12
3) from Baseline to Week 12

1) Desde el inicio hasta la semana 12
2) Desde el inicio hasta la semana 12
3) Desde el inicio hasta la semana 12

E.5.2

Secondary end point(s)

1) Percentage of subjects who achieve a PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2 grade improvement
2) Absolute change in truncal non-inflammatory lesion count
3) Absolute change in truncal inflammatory lesion count

1) Porcentaje de pacientes que alcanzan una puntuación PGA de 1 (casi limpio) o 0 (limpio) y una mejoría de al menos 2 grados
2) Cambio absoluto en el recuento de lesiones no inflamatorias troncales
3) Cambio absoluto en el recuento de lesiones inflamatorias troncales

E.5.2.1

Timepoint(s) of evaluation of this end point

1) from Baseline to Week 12
2) from Baseline to Week 12
3) from Baseline to Week 12

1) Desde el inicio hasta la semana 12
2) Desde el inicio hasta la semana 12
3) Desde el inicio hasta la semana 12

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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)

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Czech Republic

Hungary

Poland

Romania

Russian Federation

Spain

Ukraine

United States

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

Ultima visita ultimo paciente (UVUP)

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

720

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

672

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

478

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-10-30.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Minors

Menores

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

672

F.4.2.2

In the whole clinical trial

1200

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

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

2016-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-05-12

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