Clinical Trials Register

Summary
EudraCT Number:	2019-002851-40
Sponsor's Protocol Code Number:	CLOTAIS01/2019
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-06-29
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2019-002851-40

A.3

Full title of the trial

A Randomized, Parallel Design, Multiple-Site Study to Evaluate the non-inferiority of generic Clotrimazole 10mg/g cream (Antibiotice SA) compared to Canesten® 10mg/g cream in Patients with Tinea Pedis

Randomizált, párhuzamos elrendezésű, multicentrikus vizsgálat a generikus Clotrimazole 10 mg/g krém (Antibiotice SA) a Canesten® 10 mg/g krémmel szembeni non-inferioritásának értékelésére Tinea pedisben szenvedő betegeknél

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

CLOTAIS01/2019

A.4.1

Sponsor's protocol code number

CLOTAIS01/2019

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	ANTIBIOTICE SA
B.1.3.4	Country	Romania
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	ANTIBIOTICE SA
B.4.2	Country	Romania
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ANTIBIOTICE SA
B.5.2	Functional name of contact point	Mihaela Mosnegutu
B.5.3	Address:
B.5.3.1	Street Address	Str. Valea Lupului, nr 1
B.5.3.2	Town/ city	Iasi
B.5.3.3	Post code	707410
B.5.3.4	Country	Romania
B.5.4	Telephone number	+40720633164
B.5.6	E-mail	mihaela.mosnegutu@antibiotice.ro

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	Clotrimazol ATB 10mg/g cream
D.2.1.1.2	Name of the Marketing Authorisation holder	ANTIBIOTICE SA
D.2.1.2	Country which granted the Marketing Authorisation	Romania
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	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
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.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	Canesten 10mg/g cream
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER SRL
D.2.1.2	Country which granted the Marketing Authorisation	Romania
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	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
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

Tinea Pedis

Lábgombásodás bőrbetegség

E.1.1.1

Medical condition in easily understood language

Tinea Pedis (Athlete's foot)

Lábgombásodás bőrbetegség

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10043873
E.1.2	Term	Tinea pedis
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

Therapeutic cure (clinical and mycological cure) at day 28.
Clinical Cure is based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning.
Each clinical symptom will be evaluated using a 0-3 points rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient is considered a Clinical Cure

Terápiás gyógyulás (klinikai és mikológiai gyógyulás) a 28. napon.
A klinikai gyógyulás a következő jeleken és tüneteken alapul: berepedés, erythema, maceráció, hólyagosodás, hámlás, exudáció, viszketés, égő érzés.
Minden klinikai tünetet 0-3 pontos skála alapján értékelünk: nincs=0, enyhe=1, közepes=2 vagy súlyos=3. Ha az erythema pontszám ≤ 2, és a többi 7 jel és tünet összege <2, akkor a beteg klinikailag gyógyultnak minősül
Mikológiai gyógyulás - A kálium-hidroxid (KOH) és a gombatenyésztés eredménye egyaránt negatív

E.2.2

Secondary objectives of the trial

1. Therapeutic Cure – subjects with clinical and mycological cure at day 7
2. Mycologic Cure at day 28- Negative KOH and fungal culture at day 28
3. Clinical cure at day 28 – the following signs and symptoms are rated at each visit: Erythema; Fissuring Maceration; Vesiculation; Desquamation/scaling; Exudation Pruritus; Stinging/Burning.
Each symptom is evaluated using the following scale:
0 = None- Complete absence of any sign or symptom
1= Mild - obvious but minimal involvement
2= Moderate - something that is easily noted
3= Severe - quite marked
Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2
4. Safety Profile comparison between the 2 treatment arms
5. Impact of tinea pedis infection on Quality of Life (QoL)

1. Terápiás gyógyulás - azok a betegek, akiknél a 7. napon klinikai és mikológiai gyógyulás áll fenn
2. Mikológiai gyógyulás a 28. napon - Negatív KOH és gombatenyésztési eredmény a 28. napon
3. Klinikai gyógyulás a 28. napon - a következő jeleket és tüneteket értékeljük minden egyes vizit alkalmával: Erythema; repedéssel járó maceráció; hólyagképződés; deszkvamáció/hámlás; exudációs pruritusz; csípő/égő érzés.
4. Biztonságossági profil összehasonlítása a 2 kezelési kar között
5. A tinea pedis fertőzés hatása az életminőségre (QoL)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adults between 18 and 80 years, both genders
2. Skin fungal culture obtained at baseline at the target site. Only subjects with a pre-treatment baseline skin fungal culture from the target site that is positive for T. rubrum, T. mentagrophytes or E. flocossum are to be included in the primary endpoint analysis. Subjects with a negative baseline fungal culture will be excluded from the primary endpoint analysis but included in the safety population for the safety analysis.
3. The presence of tinea pedis infection, with lesions localized to the interdigital spaces and/or plantar lesions and/or sides and/or dorsum of the involved foot and confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination
4. A target lesion will be identified as the most severe lesion and evaluated throughout the study. At inclusion, the sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus (on a scale of 0 to 3, where 2 indicates moderate severity).
5. Female of child bearing potential are to use a reliable method of contraception during the study (condom, intra-uterin device, oral, transdermal, injected or implanted hormonal contraceptives)
6. The subject is willing and able to consent for the participation in the clinical trial
7. Subject must be able to understand the requirements of the study and willing to comply with the study requirements.

1. 18 és 80 év közötti életkor, mindkét nem
2. A kiindulási időpontban a célterületről vett bőrgomba tenyésztés. Az elsődleges végpontelemzéshez csak azok a betegek vehetők figyelembe, akiknél a kezelés előtti, célterületről vett mintán végzett kiindulási bőrgomba tenyésztés eredménye T. rubrum, T. mentagrophytes vagy E. flocossum gombára pozitív.
3. Tinea pedis fertőzés jelenléte, az érintett lábfejen az ujjak között és/vagy talpi részén és/vagy oldalsó részén és/vagy lábháti részén lokalizált elváltozásokkal, amelyeket a kálium-hidroxid (KOH) nedves fixálással végzett mikroszkópos vizsgálat során szegmentált gombahifák megfigyelése igazol
4. A cél-lézió a legsúlyosabb elváltozás lesz, amelyet a vizsgálat során mindvégig értékelünk. A bevonáskor a cél-lézió klinikai jeleinek és tüneteinek összege legalább 4, ezen belül az erythema legalább 2 pont és a hámlás vagy a viszketés legalább 2 pont (0-tól 3-ig terjedő skálán, ahol a 2 közepes súlyosságot jelez).
5. A fogamzóképes nőknek a klinikai vizsgálat időtartama alatt megbízható fogamzásgátlási módszert kell alkalmazniuk (óvszer, méhen belüli eszköz, orális, transzdermális, injekcióban adott vagy beültetett hormonális fogamzásgátlók)
6. A beteg hajlandó és képes beleegyezni a klinikai vizsgálatban való részvételbe
7. A betegnek képesnek kell lennie megérteni a vizsgálat előírásait, és hajlandónak kell lennie arra, hogy teljesítse a vizsgálati előírásokat.

E.4

Principal exclusion criteria

1. Known treatment with oral or injectable steroids during the study period
2. Any oral antifungals within 4 weeks of the study inclusions
3. Use of topical corticosteroids or any other topical antipruritic agents on the feet within 72 hours of the study start
4. Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
5. Use of any antihistamines within 72 hours of the study start and during the study
6. Any known hypersensitivity to antifungal agents
7. Evidence of any concurrent dermatophytes infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis
8. Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy
9. Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance
10. Subjects who in Investigator's opinion would be non-compliant
11. Female subjects that are pregnant or lactating or planning to become pregnant during the study period

1. Ismert orális vagy injekcióban adott szteroiddal végzett kezelés a vizsgálati időszakban
2. Bármilyen szájon át szedett gombaellenes szer a vizsgálatba való bevonást megelőző 4 héten belül
3. Helyi kortikoszteroid vagy más helyi antipruritikus szerek alkalmazása a lábon a vizsgálat kezdete előtti 72 órában
4. Bármilyen vényköteles vagy vény nélkül kapható helyi gombaellenes szer alkalmazása a lábfejen a vizsgálatba való belépést megelőző két héten belül
5. Bármilyen antihisztamin alkalmazása a vizsgálat kezdetét megelőző 72 órán belül és a vizsgálat folyamán
6. Gombaellenes szerrel szembeni ismert túlérzékenység
7. A lábujjkörmöket érintő egyidejű dermatofita fertőzés (onychomycosis) vagy egyéb, lábat érintő bőrgyógyászati állapot igazolt fennállása, amely zavarhatja a vizsgálót a tinea pedis értékelésében
8. Kiújuló tinea pedisben szenvedő betegek (több mint 3 fertőzés az elmúlt 12 hónapban), akik nem reagáltak a korábbi gombaellenes kezelésre
9. Túlzott mennyiségű alkoholfogyasztás, kábítószer abúzus, vagy bármilyen olyan állapot, amely miatt esetleg nem tudja teljesíteni az előírásokat
10. Olyan betegek, akik a vizsgáló véleménye szerint nem teljesítenék az előírásokat
11. Női betegek, akik terhesek vagy szoptatnak, vagy a vizsgálati időszak alatt teherbe szeretnének esni

E.5 End points

E.5.1

Primary end point(s)

Therapeutic cure at day 28

klinikai gyógyulás a 28 napon.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 4 - day 28

Visit 4 - nap 28

E.5.2

Secondary end point(s)

Therapeutic cure at day 7;
Mycological cure at day 28;
Clinical cure at day 28;
Safety profile comparison
Impact on QoL

Therapeutic gyógyulás d 7;
Mycological gyógyulás d 28;
Clinical gyógyulás d 28;
Safety profile összehasonlitás
QoL

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 7 and day 28

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

Non-Inferiority

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

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

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

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

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 - LPLV

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

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:

500

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

184

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

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

250

F.4.2

For a multinational trial

F.4.2.1

In the EEA

684

F.4.2.2

In the whole clinical trial

684

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

2022-06-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-15

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

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