Clinical Trials Register

Summary
EudraCT Number:	2021-000865-33
Sponsor's Protocol Code Number:	HUA_AFF_PRP_21
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:	2021-06-23
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

2021-000865-33

A.3

Full title of the trial

Randomized, parallel controlled study with routine clinical practice to evaluate the efficacy and tolerability of PRFC ENDORET® in the treatment of frontal fibrosing alopecia

Estudio aleatorizado, paralelo controlado con práctica clínica habitual para evaluar la eficacia y tolerabilidad del PRGF® ENDORET® en el tratamiento de la alopecia frontal fibrosante.

A.3.1

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

Randomized, parallel controlled study with routine clinical practice to evaluate the efficacy and tolerability of PRFC ENDORET® in the treatment of frontal fibrosing alopecia

Estudio aleatorizado, paralelo controlado con práctica clínica habitual para evaluar la eficacia y tolerabilidad del PRGF® ENDORET® en el tratamiento de la alopecia frontal fibrosante.

A.3.2

Name or abbreviated title of the trial where available

PRP - Fibrosing Frontal Alopecia

PRP - Alopecia Frontal Fibrosante

A.4.1

Sponsor's protocol code number

HUA_AFF_PRP_21

A.5.4

Other Identifiers

Name:

PRP - AFF

Number:

HUA_AFF_PRP_21

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	INSTITUTO DE INVESTIGACIÓN SANITARIA BIOARABA
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	INSTITUTO DE INVESTIGACIÓN SANITARIA BIOARABA
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	INSTITUTO DE INVESTIGACIÓN SANITARIA BIOARABA
B.5.2	Functional name of contact point	BIOARABA
B.5.3	Address:
B.5.3.1	Street Address	JOSE ANCHOTEGUI S/N
B.5.3.2	Town/ city	VITORIA-GASTEIZ
B.5.3.3	Post code	01009
B.5.3.4	Country	Spain
B.5.6	E-mail	maria.caberozamorano@osakidetza.eus

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	Yes
D.2.1.1.1	Trade name	PRFC-ENDORET
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	PRFC ENDORET
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRGF-Endoret
D.3.9.3	Other descriptive name	Autologous platelet rich plasma and blood cells, peripheral blood-derived
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1 to 4
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)	No
D.3.11.7	Plasma derived medicinal product	Yes
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	CLOBISDIN 500 microgramos / ml solución cutánea
D.2.1.1.2	Name of the Marketing Authorisation holder	Isdin, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Cutaneous solution
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	CLOBETASOL PROPIONATE
D.3.9.3	Other descriptive name	Clobetasol propionato
D.3.9.4	EV Substance Code	SUB01346MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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

• Patients diagnosed with fibrosing frontal alopecia (FFA) with an age greater than or equal to 18 years.
• Patient not responding to previous treatments for at least 6 months.
• Use of effective physical or pharmacological contraceptive measures
• Free acceptance to participate in the trial, with the written informed consent of the volunteer.

• Pacientes diagnosticados de alopecia frontal fibrosante (AFF) con edad mayor o igual a 18 años.
• Paciente no respondedor a tratamientos previos durante al menos 6 meses.
• Utilización de medidas anticonceptivas eficaces físicas o farmacológicas.
• Aceptación libre de participar en el ensayo, con consentimiento informado por escrito del voluntario.

E.1.1.1

Medical condition in easily understood language

Frontal Fibrosing Alopecia

Alopecia Frontal Fibrosante

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

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 PRFC ENDORET® as an adjunct treatment to routine clinical practice (topical solution of clobetasol) in the improvement of skin lesions of AFF through the change in the score of the “FFASS-Frontal Fibrosing Alopecia Severity Score

Evaluar la eficacia del PRGF®-ENDORET® como tratamiento adyuvante a la práctica clínica habitual (solución tópica de clobetasol) en la mejora de las lesiones cutáneas de la AFF a través del cambio en la puntuación de la escala “FFASS-Frontal Fibrosing Alopecia Severity Score”.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of the PRFC ENDORET® as an adjunct treatment to routine clinical practice (clobetasol topical solution) in improving the quality of life of patients through the change in the score of the Hair Specific Skindex questionnaire29.
Evaluate the patient's impression of improvement through the patient's global impression of improvement scale. (PGI-I)
Assess the clinician's impression of improvement through the global clinical improvement scale (CGI-GI)
Evaluate the safety and tolerability of the PRFC ENDORET® as an adjunct treatment to routine clinical practice by recording adverse effects and guaranteeing the safety of the study patients.

Evaluar la eficacia del PRGF® ENDORET® como tratamiento adyuvante a la práctica clínica habitual (solución tópica de clobetasol) en la mejora de la calidad de vida de los pacientes a través del cambio en la puntuación del cuestionario Hair Specific Skindex29.
Evaluar la impresión de mejoría del paciente a través de la escala de impresión de mejoría global del paciente. (PGI-I)
Evaluar la impresión de mejoría del clínico a través de la escala de mejoría clínica global (CGI-GI).
Evaluar la seguridad y tolerabilidad del PRGF® ENDORET® como tratamiento adyuvante a la práctica clínica habitual mediante el registro de los efectos adversos y garantizar la seguridad de los pacientes del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

E.4

Principal exclusion criteria

• Hematological or bleeding disorders.
• Diagnosed platelet dysfunction.
• Use of anticoagulant therapy or non-steroidal anti-inflammatory drugs in the 5 days prior to the extraction of the blood sample.
• Cancer and / or treatment with chemotherapy and / or radiotherapy.
• Topical or intralesional use of corticosteroids in the previous 4 weeks.
• Severe or multiple allergy to medications.
• Allergy or intolerance to any component of the study products (including peanuts and / or soybeans)
• Hypersensitivity to calcium chloride and / or calcium citrate.
• Patients who are immunosuppressed or who have received immunosuppressive treatment in the previous 12 weeks.
• Presence of untreated thyroid disease.
• Local or systemic infections.
• Infectious processes, folliculitis, facial herpes or uncontrolled pigmentation disorders.
• Patients undergoing chemical peeling, laser or any other type of facial treatment during the previous 6 months.
• Any medical or psychiatric condition that makes it difficult, according to clinical judgment, to participate in the study.
• Being participating in another research study.
• Patients with unattainable expectations.
• Pregnancy and / or breastfeeding.

• Desórdenes hematológicos o de sangrado.
• Disfunción plaquetaria diagnosticada.
• Uso de terapia anticoagulante o antiinflamatorios no esteroideos en los 5 días previos a la extracción de la muestra de sangre.
• Cáncer y/o tratamiento con quimioterapia y/o radioterapia.
• Uso tópico o intralesional de corticoides en las 4 semanas previas.
• Alergia severa o múltiple a medicamentos.
• Alergia o intolerancia a cualquier componente de los productos del estudio (incluyendo cacahuete y/o soja).
• Hipersensibilidad a cloruro de calcio y/o citrato de calcio.
• Pacientes inmunodeprimidos o que hayan recibido tratamiento inmunosupresor en las 12 semanas previas.
• Presencia de enfermedad tiroidea no tratada.
• Infecciones locales o sistémicas.
• Procesos infecciosos, foliculitis, herpes facial o trastornos de la pigmentación no controlados.
• Pacientes sometidos a tratamientos de peeling químico, láser o cualquier otro tipo de tratamiento facial durante los 6 meses anteriores.
• Cualquier condición médica o psiquiátrica, que dificulte según juicio clínico su participación en el estudio.
• Estar participando en otro estudio de investigación.
• Pacientes con expectativas inalcanzables.
• Embarazo y/o lactancia.

E.5 End points

E.5.1

Primary end point(s)

To evaluate the efficacy of PRFC ENDORET® as an adjunct treatment to routine clinical practice (topical solution of clobetasol) in the improvement of AFF skin lesions through the change in the score of the “FFASS-Frontal Fibrosing Alopecia Severity Score”.

E.5.1.1

Timepoint(s) of evaluation of this end point

FFASS will be assessed at 4 and 12 weeks after the start of the treatment and at 4 and 12 weeks after the end of the treatment.

FFASS se evaluará a las 4 y 12 semanas después del inicio del tratamiento y a las 4 y 12 semanas después del final del tratamiento.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Hair Specific Skindex questionnaire29 will be assessed at 4 and 12 weeks after the start of the treatment and at 4 and 12 weeks after the end of the treatment.
Patient's global impression of improvement scale. (PGI-I) will be assessed at 12 weeks after the end of the treatment.
Global clinical improvement scale (CGI-GI) will be assessed at 4 and 12 weeks after the start of the treatment and at 4 and 12 weeks after the end of the treatment.
Evaluate the safety and tolerability along all the study.

El cuestionario Hair Specific Skindex29 se evaluará a las 4 y 12 semanas después del inicio del tratamiento y a las 4 y 12 semanas después del final del tratamiento.
Escala de impresión global de mejora del paciente. (PGI-I) se evaluará a las 12 semanas después del final del tratamiento.
La escala de mejoría clínica global (CGI-GI) se evaluará a las 4 y 12 semanas después del inicio del tratamiento y a las 4 y 12 semanas después del final del tratamiento.
Evaluar la seguridad y tolerabilidad a lo largo de todo el estudio.

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

Yes

E.8.1.7.1

Other trial design description

Ciego para el análisis

Blind for the analysis

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

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

Last patient last visit

Último paciente última visita

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)

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

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

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

F.4.2.2

In the whole clinical trial

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

2021-10-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-30

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

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