Clinical Trials Register

Summary
EudraCT Number:	2016-001106-42
Sponsor's Protocol Code Number:	16-01/CalciBet-Gel
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-07-25
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

Germany - BfArM

A.2

EudraCT number

2016-001106-42

A.3

Full title of the trial

Double-blind, randomised clinical study comparing efficacy and safety of Calcipotriol 50 µg/g_Betamethasone 0.5 mg/g Gel (Test) vs. Daivobet(R) Gel (Reference) vs. Vehicle in patients with scalp psoriasis

A.3.1

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

Clinical study to compare two gels with the active substance calcipotriol and betamethasone and one gel without active substance for patients with scalp psoriasis

A.4.1

Sponsor's protocol code number

16-01/CalciBet-Gel

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	Dermapharm AG
B.1.3.4	Country	Germany
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	Dermapharm AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dermapharm AG
B.5.2	Functional name of contact point	Clinical Department
B.5.3	Address:
B.5.3.1	Street Address	Lil-Dagover-Ring 7
B.5.3.2	Town/ city	Grünwald
B.5.3.3	Post code	82031
B.5.3.4	Country	Germany
B.5.4	Telephone number	00498964186166
B.5.5	Fax number	00498964186110
B.5.6	E-mail	betina.fuerden@dermapharm.de

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	Calcipotriol 50 µg/g_Betamethasone 0.5 mg/g Gel
D.3.4	Pharmaceutical form	Gel
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	BETAMETHASONE DIPROPIONATE
D.3.9.1	CAS number	5593-20-4
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	BETAMETHASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00783MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.643
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIPOTRIOL MONOHYDRATE
D.3.9.1	CAS number	147657-22-5
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	CALCIPOTRIOL MONOHYDRATE
D.3.9.4	EV Substance Code	SUB26081
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.052
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	Daivobet(R) 50 Mikrogramm/g + 0,5 mg/g Gel
D.2.1.1.2	Name of the Marketing Authorisation holder	Leo Pharma A/S
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Daivobet 50 Mikrogramm/g + 0.5 mg/g Gel
D.3.4	Pharmaceutical form	Gel
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	BETAMETHASONE DIPROPIONATE
D.3.9.1	CAS number	5593-20-4
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	BETAMETHASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00783MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.643
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIPOTRIOL MONOHYDRATE
D.3.9.1	CAS number	147657-22-5
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	CALCIPOTRIOL MONOHYDRATE
D.3.9.4	EV Substance Code	SUB26081
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.052
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Gel
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

Psoriasis capitis

E.1.1.1

Medical condition in easily understood language

Psoriasis of scalp

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10037157
E.1.2	Term	Psoriasis of scalp
E.1.2	System Organ Class	100000018190

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 and safety of a new gel containing 50 µg/g calcipotriol and 0.5 mg/g betamethasone vs. the originator Daivobet (R) Gel vs. vehicle in patients with psoriasis of the scalp.

see also E5 (endpoints)

E.2.2

Secondary objectives of the trial

see E5 (endpoints)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Women and men ≥ 18 years of age
• Written consent to study participation after patient information by the investigator
• Diagnosis of “scalp psoriasis vulgaris” according to generally accepted criteria
• Extent of scalp psoriasis involving at least 20% of the total scalp area
• For the score values of the activity parameters erythema, desquamation, induration and pruritus (each assessed on a scale from 0 to 3) the following applies:
o Sum score of all four parameters ≥ 6 and
o Desquamation and erythema ≥ 4 and
o Desquamation ≥ 2.
• For women of childbearing potential: Application of an efficient contraceptive method during the whole study
• For women of childbearing potential: Pregnancy test with negative result prior to study start

E.4

Principal exclusion criteria

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis
• Systemic therapy of psoriasis within the last 4 weeks before study inclusion
• Any topical treatment or physical therapy (e.g. UV radiation, retinoids, corticosteroids) of scalp psoriasis within the last 2 weeks before study inclusion
• Known intolerance or hypersensitivity against calcipotriol, betamethasone or other glucocorticoids or any of the other ingredients in the study medication
• History of psoriasis unresponsive to topical treatment
• Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
• Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), fungal and bacterial skin infections, parasitic infections, skin manifestions in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds
• Other inflammatory skin disease in the treatment area that may confound the evaluation of the scalp psoriasis (e.g. atopic dermatitis, contact dermatitis, tinea capitis)
• Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment area, which could interfere with the rating of efficacy and safety parameters
• Other severe acute or chronic concomitant disease with severe impairment of the general condition
• Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
• Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
• Reasonable doubt concerning the co-operation of the patient
• Participation in another clinical study within the last 30 days prior to inclusion in this study
• Participation in this study at an earlier date
• Women with existing or intended pregnancy or during lactation

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint to be analysed is the change of the modified Total Severity Sign Score (mTSS) between start of treatment (Visit 1) and the end of treatment (Visit 5). The mTSS consists of the activity parameters erythema, desquamation, induration and pruritus.

E.5.1.1

Timepoint(s) of evaluation of this end point

Start of therapy (Visit 1) and end of therapy (Visit 5)

E.5.2

Secondary end point(s)

• Change of the extent of the scalp psoriasis at each visit
• Course of the individual activity parameters erythema, desquamation, induration and pruritus at Visit 1, Visit 2, Visit 3, Visit 4 and Visit 5, respectively
• Change of the modified Total Severity Sign Score (mTSS) between start of treatment (Visit 1) and Visit 2, Visit 3, Visit 4 and Visit 5, respectively
• Change of the Psoriasis Scalp Severity Index calculated by multiplying each mTSS with the area of the scalp covered by psoriasis between visits
• Change of the Investigator`s Global Assessment (IGA) between visits
• Proportion of patient with “absence of disease” or “very mild disease” according to the IGA at Visit 5
• Evaluation of Overall Therapeutic Success by the investigator and patient at the final examination
• Number and classification of adverse events
• Evaluation of tolerability by the investigator and by the patient at all visits under treatment

E.5.2.1

Timepoint(s) of evaluation of this end point

Depends on the secondary endpoint, see E.5.2 above

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

Yes

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)

Yes

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

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

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 Visit Last Subject

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:

225

F.1.3

Elderly (>=65 years)

Yes

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

225

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 (no post trial treatment) but normal treatment based on the clinical judgement of the investigator

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

2016-08-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-19

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

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