Clinical Trials Register

Summary
EudraCT Number:	2013-001753-26
Sponsor's Protocol Code Number:	DC0984LE401
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-09-28
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

France - ANSM

A.2

EudraCT number

2013-001753-26

A.3

Full title of the trial

Clinical and biophysics evaluation of the cutaneous modifications following the local use of a lotion containing 0,1 % of trétinoïne.

Evaluation clinique et biophysique des modifications cutanées secondaires à l’utilisation locale d’une lotion contenant 0,1% de trétinoïne.

A.3.1

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

Evaluation of the cutaneous modifications following the local use of an anti acneic lotion.

Evaluation des modifications cutanées secondaires à l’utilisation locale d’une lotion anti-acnéique.

A.4.1

Sponsor's protocol code number

DC0984LE401

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	Pierre Fabre Dermo-cosmétique
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	Pierre Fabre Dermo-cosmétique
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	Pierre Fabre Dermo-cosmétique
B.5.2	Functional name of contact point	QUESTEL
B.5.3	Address:
B.5.3.1	Street Address	Centre de Recherche sur la Peau, 2 rue Viguerie, BP 3071, Cedex 3
B.5.3.2	Town/ city	TOULOUSE
B.5.3.3	Post code	31025
B.5.3.4	Country	France
B.5.4	Telephone number	33562488505
B.5.5	Fax number	33562488599
B.5.6	E-mail	emmanuel.questel@pierre-fabre.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	Yes
D.2.1.1.1	Trade name	LOCACID 0.1% lotion
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre Fabre Dermatologie
D.2.1.2	Country which granted the Marketing Authorisation	France
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 liquid
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	tretinoin
D.3.9.1	CAS number	302-79-4
D.3.9.4	EV Substance Code	SUB11246MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
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

Acne

Acné

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	18.0
E.1.2	Level	HLT
E.1.2	Classification code	10000497
E.1.2	Term	Acnes
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10000496
E.1.2	Term	Acne
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	SOC
E.1.2	Classification code	10040785
E.1.2	Term	Skin and subcutaneous tissue disorders
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	HLGT
E.1.2	Classification code	10040798
E.1.2	Term	Skin appendage conditions
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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

Measure the evolution on 21 days of the skin dryness consecutive to the local application of trétinoïne treatment compared with an untreated zone.

Mesurer l’évolution sur 21 jours de la sécheresse cutanée consécutive à l’application locale d’un traitement à base de trétinoïne comparativement à une zone témoin non traitée.

E.2.2

Secondary objectives of the trial

Measure by clinical, biometrological, spectroscopiques, biochemical, molecular and illustrative methods, some criterion associated to the skin dryness consecutive to the local application of a trétinoïne treatment.

Mesurer par des méthodes cliniques, biométrologiques, spectroscopiques, biochimiques, moléculaires et illustratives, différents critères associés à la sécheresse cutanée consécutive à l’application locale d’un traitement à base de trétinoïne.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Relative to the population:
O male Adult.
O Age included between 18 and 30 inclusive years.
O Phototype I to IV
o Pilosity reduced at the level of the top of the back
o Subject affiliated to a French national insurance scheme,
o Subject having given its written consent to its participation in the study.
O Registration in the national file of the persons who lend themselves to biomedical researches.

Relative to the pathology:
Subject having a moderated acne at the level of the back, the evaluation by the investigator global assessment of the acne (rank 1, 2, 3)

Relatifs à la population :
o Adulte de sexe masculin.
o Age compris entre 18 et 30 ans inclus.
o Phototype I à IV
o Pilosité réduite au niveau de la partie supérieure du dos
o Sujet affilié à un régime de sécurité sociale français,
o Sujet ayant donné son consentement écrit à sa participation à l’étude.
o Inscription au fichier national des personnes qui se prêtent à des recherches biomédicales.

Relatifs à la pathologie :
Sujet ayant une acné minime à modérée au niveau du dos, évaluation par l’investigateur sur une échelle classique globale de l’acné (grade 1, 2, 3)

E.4

Principal exclusion criteria

Relative to the pathologies:
· Any dermatological pathology on the back, other than the acne.
· Existence of a chronic affection or an evolutionary acute pathology which can interfere with the study.

Relative to treatments:
· Use of a self-tanning, keratolytic or exfoliating product on the back in 2 weeks preceding the inclusion.
· Use on the back of any product which can interfere with the study (produced moisturizer, care product) in 2 weeks preceding the inclusion.
· Treatment by oral route by antibiotics in 2 weeks preceding the inclusion.
· Treatment by oral route by anti-inflammatory or corticoid during more than 2 consecutive days in 2 weeks preceding the inclusion.
- Treatment by local use on the study zone : by anti-inflammatory, corticoid or antibiotics during more than 2 consecutive days in 2 weeks preceding the inclusion.
· Hormonal treatment (in thyroid, anti-acned) by oral route in two months preceding the inclusion.
· Any anti-acned treatment:
O By local use on the study zone (acid azélaique, peroxide of benzoyle, antibiotics, rétinoïdes) in the month preceding the beginning of the study,
o By oral use: antibiotics (tétracyclines or macrolides) or zinc in the month preceding the beginning of the study,
o By oral use: rétinoïdes in 6 months preceding the beginning of the study.
· Allergy or for intolerance in one of the components of the LOCACID lotion ®.
· Histories known for allergy or intolerance to the latex.

Relative to the population:
· Exposure the back to the sun planned during the study.
· Presence on the experimental zone of solar erythema or other mark which can interfere with the evaluation of the cutaneous reactions (pigmentation disorders, tattoo).
· Participation in a clinical trial on the back in the week preceding the inclusion.
· Subject in the impossibility to conform to theprotocol requirements.
· Subject having perceived, within the framework of clinical trials, compensations superior to 4 500 euros, this included study, during the last 12 months.
· Subject in incapacity to understand the information (for linguistic or psychiatric causes) and to give its consent.
• Subject confiscated his liberty by administrative or legal decision or guardianship.
· Subject which participates at present or which participated in another clinical trial and being in period of exclusion during which he can not participate to another clinical trial.

Relatifs aux pathologies :
• Toute pathologie dermatologique au niveau du dos, autre que l’acné.
• Existence d’une affection chronique ou d’une pathologie aiguë évolutive pouvant interférer avec l’étude.

Relatifs aux traitements :
• Utilisation d’un produit auto-bronzant, kératolytique ou exfoliant au niveau du dos dans les 2 semaines précédant l’inclusion.
• Utilisation au niveau du dos de tout produit pouvant interférer avec l’étude (produit hydratant, produit de soin,…) dans les 2 semaines précédant l’inclusion.
• Traitement par voie orale par antibiotiques dans les 2 semaines précédant l’inclusion.
• Traitement par voie orale par anti-inflammatoires ou corticoïdes pendant plus de 2 jours consécutifs dans les 2 semaines précédant l’inclusion.
• Traitement par voie locale sur la zone à l’étude par anti-inflammatoires, corticoïdes ou antibiotiques pendant plus de 2 jours consécutifs dans les 2 semaines précédant l’inclusion.
• Traitement hormonal (à visée thyroïdienne, anti-acnéique) par voie orale dans les deux mois précédant l’inclusion.
• Tout traitement anti-acnéique :
o Par voie locale sur la zone à l’étude (acide azélaique, peroxyde de benzoyle, antibiotiques, rétinoïdes...) dans le mois précédant le début de l’étude,
o Par voie générale, par antibiotiques (tétracyclines ou macrolides) ou par le zinc dans le mois précédant le début de l’étude,
o Par voie générale par rétinoïdes dans les 6 mois précédant le début de l’étude.
• Antécédents connus d’allergie ou d’intolérance à un des composants du LOCACID lotion®.
• Antécédents connus d’allergie ou d’intolérance au latex.

Relatifs à la population :
• Exposition solaire du dos prévue pendant l’étude.
• Présence sur la zone expérimentale d’érythème solaire ou autre marque pouvant interférer avec l'évaluation des réactions cutanées (troubles de la pigmentation, tatouage...).
• Participation à une étude clinique au niveau du dos dans la semaine précédant l’inclusion.
• Sujet dans l’impossibilité de se conformer aux exigences du protocole.
• Sujet ayant perçu, dans le cadre d’études cliniques, des indemnités supérieures à 4 500 euros, cette étude comprise, au cours des 12 derniers mois.
• Sujet en incapacité de comprendre l’information (pour des causes linguistiques ou psychiatriques) et de donner son consentement à la participation.
• Sujet confisqué de sa liberté par décision administrative ou légale ou sous tutelle.
• Sujet qui participe actuellement ou qui a participé à une autre étude clinique et se trouvant en période d’exclusion au cours de laquelle il ne peut participer à aucune autre recherche biomédicale.

E.5 End points

E.5.1

Primary end point(s)

SRRC score which measures the skin dryness at day 1 and day 22

Score SRRC mesurant la sécheresse cutanée à Jour 1 et Jour 22

E.5.1.1

Timepoint(s) of evaluation of this end point

day 1 and day 22

Jour 1 et Jour 22

E.5.2

Secondary end point(s)

Some criterion linked to the skin dryness.

Différents critères associés à la sécheresse cutanée.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1, day 8, day 15, day 22

Jour 1, Jour 8, Jour 15, Jour 22

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

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

Clinical study: research and development

Etude clinique : recherche et développement

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

controlatéral

controlateral

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

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

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.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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

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

2013-07-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-02-20

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IMP with orphan designation in the indication
Orphan Designation Number:
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