Clinical Trials Register

Summary
EudraCT Number:	2011-002135-26
Sponsor's Protocol Code Number:	4PH/2011/002
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-27
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002135-26

A.3

Full title of the trial

Efficacy and Safety of Acyclovir 5 Lipstick (Contra) in Treatment of Skin Infections Provoked by Herpes Simplex. A Randomised, Double-blind, Placebo Controlled, Parallel Group Study.

Efficacia e sicurezza di Acyclovir 5 stick labiale nel trattamento delle infezioni della pelle provocate dall'Herpes Simplex. Uno studio parallelo, randomizzato, in doppio cieco, controllato verso placebo

A.3.1

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

Efficacy and Safety of Acyclovir Lipstick (Contra) in Treatment of Skin Infections Provoked by Herpes Simplex

Efficacia e sicurezza di Acyclovir stick labiale nel trattamento delle infezioni della pelle provocate dall’Herpes Simplex.

A.3.2

Name or abbreviated title of the trial where available

4PH/2011/002

A.4.1

Sponsor's protocol code number

4PH/2011/002

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	AESCULAPIUS FARMACEUTICI S.R.L.
B.1.3.4	Country	Italy
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	aesculapius farmaceutici srl
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	fourpharma srl
B.5.2	Functional name of contact point	informazione sulla sperimentazione
B.5.3	Address:
B.5.3.1	Street Address	plebiscito 4
B.5.3.2	Town/ city	sulmona
B.5.3.3	Post code	67039
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39.3474554772
B.5.5	Fax number	+39.0864.210462
B.5.6	E-mail	clinica@fourpharma.it

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	EFRIVIRALLABIALE*MAT CUT 3G 5%
D.2.1.1.2	Name of the Marketing Authorisation holder	AESCULAPIUS FARMACEUTICI Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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 stick
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	NA
D.3.9.1	CAS number	59277-89-3
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	5
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	Yes
D.3.11.13.1	Other medicinal product type	e' un analogo strutturale della guanina

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	Cutaneous stick
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

History of recurrent herpes labialis with at least 3 recurrences during the past 12 months and typically (>50% of episodes) associated with prodromal symptoms

PAZIENTI CON STORIA RICORRENTE DI HERPES LABIALE DURANTE I 12 MESI PRECEDENTI E ASSOCIATI CON SINTOMI PRODROMICI

E.1.1.1

Medical condition in easily understood language

PATIENTS WITH HERPES LABIALIS INFECTION DURING THE PAST 12 MONTHS

PAZIENTI CHE HANNO UNA STORIA DA INFEZIONE DA HERPES LABIALE DURANTE GLI ULTIMI 12 MESI

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10019942
E.1.2	Term	Herpes labialis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

evaluation of the efficacy of test formulation (Acyclovir 5% Lipstick from Aesculapius Farmaceutici Srl) in comparison with placebo

Valutazione dell’efficacia della formulazione test (Acyclovir 5% Lipstick di Aesculapius Farmaceutici Srl) a confronto con il placebo

E.2.2

Secondary objectives of the trial

evaluation of the general safety of the active treatment (test formulation) in comparison with placebo.

Valutazione della sicurezza generale del trattamento attivo (formulazione test) a confronto con placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Caucasian origin; - Patients with a clinical diagnosis of active infection of recurrent labial herpes in prodromal phase; - Body weight within 20% of ideal body weight; - Normal physical examination, vital signs, ECG; - Negative result of pregnancy test for female patients.

- Origine Caucasica; - Pazienti con diagnosi clinica di infezione attiva di herpes labiale ricorrente in fase prodromica; - Peso corporeo entro il 20% del peso corporeo ideale; - Valutazione fisica normale, segni vitali, ECG; - Test di gravidanza negativo per le pazienti donne.

E.4

Principal exclusion criteria

 Recent infection of Herpes Zoster in the last 4 weeks;  Treatment with other systemic or topical antiviral agents or systemic corticosteroids within 4 weeks prior to study drug administration;  Previous herpes vaccine;  Pregnant, nursing and/or lactating females;  Patients with herpetic stomatitis;  Patients with severe symptoms or signs of herpes labialis such as intraoral lesions or lesions in the nostrils; - Subjects with lesions wider than 2.0cm2; - Subjects with renal, hepatic or metabolic dysfunction that may pose a risk to the safety;

-recente infezione con Herpes Zoster nelle ultime 4 settimane -trattamento con agenti antivirali sistemici o topici o corticosteroidi nelle 4 settimane precedenti l'inizio della somministrazione -precedente vaccino verso herpes -stato di gravidanza o in allattamento - pazienti con stomatite herpetica -pazienti con sintomi o segni severi di herpes labiale con lesioni intraorali o lesioni allenarici

E.5 End points

E.5.1

Primary end point(s)

evaluation of the efficacy of test formulation (Acyclovir 5 Lipstick from Aesculapius Farmaceutici Srl) in comparison with placebo

Valutazione dell’efficacia della formulazione test (Acyclovir 5 Lipstick di Aesculapius Farmaceutici Srl) a confronto con il placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

after the LVLP

DOPO LA LVLP

E.5.2

Secondary end point(s)

evaluation of the general safety of the active treatment (test formulation) in comparison with placebo.

Valutazione della sicurezza generale del trattamento attivo (formulazione test) a confronto con placebo.

E.5.2.1

Timepoint(s) of evaluation of this end point

AFTER THE LVLP

DOPO LA LVLP

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

Number of subjects for this age range:

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)

the evalution will be done at the end of the study

verrà fatta una valutazione alla fine dello studio

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

2012-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-16

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials