Clinical Trials Register

Summary
EudraCT Number:	2016-000968-42
Sponsor's Protocol Code Number:	PRPZDSKIN
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:	2016-04-18
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

2016-000968-42

A.3

Full title of the trial

Study on the healing of the partial skin graft donor site in burn patients after application of platelet-rich plasma (PRP) or plasma rich in growth factors versus usual therapeutical practice.

Estudio sobre la cicatrización de la zona donante de injerto de piel parcial en pacientes quemados tras aplicación de plasma rico en plaquetas o plasma rico en factores de crecimiento frente a la forma terapéutica habitual.

A.3.1

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

Study on healing of the healthy skin area where the skin of the burn patients is taken to cure the burned area, after application of autologous products (obtained from the patient): The platelet-rich plasma (PRP) and plasma rich in growth factors (PRGF), compared with commonly used therapy

Estudio sobre la cicatrización de la zona sana de piel de donde se extrae la piel del propio paciente quemado para curar la zona quemada, tras aplicarle productos autólogos (obtenidos del propio paciente): el plasma rico en plaquetas (PRP) y el plasma rico en factores de crecimiento (PRGF), en comparación con la terapia utilizada habitualmente

A.4.1

Sponsor's protocol code number

PRPZDSKIN

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 INVESTIGACION SANITARIA LA FE
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 INVESTIGACION SANITARIA LA FE
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 INVESTIGACION SANITARIA LA FE
B.5.2	Functional name of contact point	UREC
B.5.3	Address:
B.5.3.1	Street Address	Avenida Fernando Abril Martorell, 106
B.5.3.2	Town/ city	VALENCIA
B.5.3.3	Post code	46026
B.5.3.4	Country	Spain
B.5.4	Telephone number	34961246611
B.5.5	Fax number	34961246620
B.5.6	E-mail	investigacion_clinica@iislafe.es

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	Platelet-rich plasma (PRP)
D.3.4	Pharmaceutical form	Cutaneous liquid
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Platelet-rich plasma (PRP)
D.3.9.3	Other descriptive name	PLATELETS, HUMAN BLOOD
D.3.9.4	EV Substance Code	SUB127875
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	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	Plasma rich in growth factors
D.3.4	Pharmaceutical form	Cutaneous liquid
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Plasma rich in growth factors
D.3.9.3	Other descriptive name	HUMAN PLASMA
D.3.9.4	EV Substance Code	SUB126372
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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.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

Study on healing the graft donor skin on burn patients

Estudio de la cicatrización de la zona donante de injerto de piel parcial de pacientes quemados

E.1.1.1

Medical condition in easily understood language

Burn patients

Pacientes quemados.

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

Study on healing the graft donor site of partial skin in burn patients after application of platelet-rich plasma or plasma rich in growth factors versus routine therapy

Estudio de la cicatrización de la zona donante de injerto de piel parcial en pacientes quemados tras aplicación de plasma rico en plaquetas o plasma rico en factores de crecimiento frente a la forma terapéutica habitual

E.2.2

Secondary objectives of the trial

1. Determine if there are significant differences in the perception of pain by the patient among the products evaluated
2. Determine if there are significant differences in the rate of infection after application of the products tested, from the collection of adverse events
3. Determine if there are significant differences in the therapeutic potential of the two products assessed (PRP and PRGF)
4. Develop a protocol for the collection and clinical use, either PRP or PRGF for the treatment of donor sites
5. Define the parameters to be evaluated when implement protocols for obtaining PRGF PRP or therapeutic purposes
6. Design a risk management system specific for this type of activity
7. Determine the cost of the proposed model and its comparison with other methodologies for the type of products evaluated in this project or with other therapeutic approaches
8. Establish the base for possible future expansion of the methodology applied to the field of major burns

Determinar si hay diferencias significativas en la percepción del dolor por parte del paciente entre los productos evaluados; Determinar si hay diferencias significativas en la tasa de infección tras la aplicación de los productos evaluados; Determinar si hay diferencias significativas en el potencial terapéutico de los dos productos evaluados (PRP y PRGF); Desarrollar un protocolo para la obtención y uso clínico, ya sea de PRP o PRGF para el tratamiento de zonas donantes; Definir los parámetros que se deben evaluar para implementar protocolos para la obtención de PRP o PRGF con fines terapéuticos; Diseñar un sistema de gestión de riesgos específico para este tipo de actividad; Determinar el coste del modelo propuesto y su comparación con otras metodologías para obtener el tipo de productos evaluados en este proyecto o bien con otras metodologías terapéuticas; Asentar las bases para una eventual ampliación de la metodología aplicada al campo de los grandes quemados

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Male or female aged between 18 and 70 years old at the time of consent
2. Subjects able to understand the informed consent form provided and who have signed voluntarily (no subject should be forced to participate in the trial), by themselves or through their family guardians or, if necessary, legal representatives
3. Subjects willing to meet all the trial requirements. They must be willing to visit the site on the dates identified in the study for the cures and the collection of photographic documentation until complete regeneration of the wound. Subjects must agree to make a follow-up visit at 1st month, 3rd, 6th and 12th months
4. Subjects with second or third degree burn likely to receive skin autografts with a minimum size of 112,5cm2
5. Subjects who develop a skin burn injury affecting a partial thickness between 0.5% and maximum 10% of the body surface
6. Patients with serology compatible with pathology

1. Hombre o mujer con edad comprendida entre los 18 y los 70 años de edad en el momento del consentimiento
2. Sujetos capaces de entender el formulario de consentimiento informado proporcionado y que lo hayan firmado de forma voluntaria (ningún sujeto debe ser obligado a participar en el ensayo), por sí mismos o a través de sus familiares custodios o, cuando sea necesario, representantes legales
3. Sujetos dispuestos a cumplir todos los requisitos del estudio clínico. Deben estar dispuestos a visitar al centro los días señalados en el estudio para las curas y la recogida de documentación fotográfica hasta la regeneración total de la herida y disposición a realizar una visita de seguimiento al mes, 3, 6 y 12 meses
4. Sujetos con quemadura de segundo o tercer grado susceptibles de recibir autoinjertos de piel con un tamaño mínimo de 112,5cm2
5. Sujetos que presenten una lesión cutánea por quemadura de espesor parcial que afecte entre un 0.5% y un máximo de 10% de la superficie corporal
6. Pacientes con serología compatible con patología

E.4

Principal exclusion criteria

1. Subjects who have a skin burn injury affecting more than the 10% of the body surface
2. Pregnant or breast-feeding
3. Diseases or conditions that, in the investigator's opinion, could interfere with the assessment of safety or efficiency
4. Patients who have a chronic skin disease or currently active that the investigator considers could adversely affect the skin regeneration
5. Subjects with medical background of coagulopathy
6. Subjects with chronic treatment of corticosteroids or other immunosuppressive drugs
7. Immunosuppressed subjects
8. Subjects affected by any acute infectious disease
9. Subjects affected by any systemic disease that can worsen the prognosis if any adverse effects occurs (patients with poorly controlled diabetes presenting retinopathy or peripheral vascular disease, severe hypertension or severe disease). Decompensation of diabetes linked to stress-induced injury or surgery is not considered exclusion criteria
10. Subjects who are part of the research team: researchers, collaborators, nurses, workers in the center or any other person directly related to the protocol development 11. Subjects with mental incapacity or language barriers that impede proper understanding of the informed consent form or cooperation or predisposition necessary to comply with the trial procedures

1.Sujetos que presenten una lesión cutánea por quemadura que afecte a más del 10% de la superficie corporal.
2. Mujeres embarazadas o en periodo de lactancia.
3. Enfermedades o trastornos que, en opinión del investigador, podrían interferir en la evaluación de la seguridad o la eficiencia.
4. Sujetos que presenten una enfermedad cutánea crónica o actualmente activa que el investigador considere que afectará de forma negativa a la regeneración dérmica.
5. Sujetos con historia de coagulopatía.
6. Sujetos con tratamiento crónico de corticosteroides u otro fármaco inmunosupresor.
7. Sujetos inmunodeprimidos.
8. Sujetos afectados por cualquier enfermedad infecciosa aguda.
9. Sujetos afectados de cualquier enfermedad sistémica que puede empeorar el pronóstico si se produce algún efecto adverso (pacientes con diabetes mal controlada que presenten retinopatía o vasculopatía periférica, hipertensión severa o enfermedad grave). Las descompensaciones puntuales de la diabetes ligadas al estrés inducido por la lesión o cirugía no se considerarán criterio de exclusión.
10. Sujetos que forman parte del equipo investigador: investigadores, colaboradores, personal de enfermería, trabajadores del centro o cualquier otra persona directamente relacionada con el desarrollo del protocolo.
11 Sujetos con incapacidad mental o barreras idiomáticas que impiden la adecuada comprensión del formulario de consentimiento informado o la cooperación o disposición necesarias para cumplir los procedimientos del estudio clínico.

E.5 End points

E.5.1

Primary end point(s)

- Total healing time, objectified by the observer. The unit of measurement used will be days.

- Tiempo de cicatrización total, objetivado por el observador. La unidad de medida utilizada serán días.

E.5.1.1

Timepoint(s) of evaluation of this end point

Days 3, 5, 8, 11, 14, 17, 20, 23, 26, 29; Months 1, 3, 6 and 12

Días 3, 5, 8, 11, 14, 17, 20, 23, 26, 29; Meses 1, 3, 6 y 12

E.5.2

Secondary end point(s)

- Pain objectified by the patient during handling of the donor skin area in subsequent follow-up visits until complete epithelialization
- Rate of infection of different therapeutic options used
- Quality of healing:
- Measure the elasticity of the skin
- Scale Vancouver.
- Scale for the assessment of the scar by patient and observer
- Quantification of the health economic expense of the treatment with these products compared to other therapeutic alternatives
- Haematological blood variables for the production of PRP and PRGF
- Concentration of growth factors PDGF, TGF-B, EGF and VEGF of the supernatant PRP coagulated and PRGF
- Determination of platelet activation during plasma processing.

- Dolor objetivado por el paciente durante el manejo de la zona donante de piel en las sucesivas visitas de seguimiento hasta la epitelización completa
- Tasa de infección de las distintas opciones terapéuticas empleadas
- Calidad de cicatrización:
? Medida de la elasticidad de la piel
? Escala de Vancouver
? Escala del Observador y Paciente para Evaluación de Cicatrices
- Cuantificación económica del gasto sanitario que supone el tratamiento con estos productos frente a otras alternativas terapéuticas
- Variables hematológicas (recuentos, hematocrito, volumen celular, etc.) de la sangre extraída para la producción de PRP y PRGF
- Concentración de los factores de crecimiento PDGF, TGF-B, EGF y VEGF del sobrenadante de PRP coagulado y PRGF
- Determinación de la activación plaquetaria durante el procesamiento del plasma
- Volumen en mililitros de PRP y PRGF necesario para la cobertura del área donante

E.5.2.1

Timepoint(s) of evaluation of this end point

Days 3, 5, 8, 11, 14, 17, 20, 23, 26, 29; Months 1, 3, 6 and 12

Días 3, 5, 8, 11, 14, 17, 20, 23, 26, 29; Meses 1, 3, 6 y 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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

El paciente actua como su propio control

Patient is his own control

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Comfeel® Plus Transparente

Comfeel® Plus Transparent

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

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

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

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.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

2016-06-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-08

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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