Clinical Trials Register

Summary
EudraCT Number:	2020-004081-19
Sponsor's Protocol Code Number:	20-01/BetaSal-S
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-08-13
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2020-004081-19

A.3

Full title of the trial

Double-blind, randomised clinical study comparing efficacy and safety of Betamethasone dipropionate 0.64 mg/g _ Salicylic acid 30 mg/g Ointment (Test) vs. Diprosalic(R) Ointment (Reference) vs. Vehicle in patients with chronic stable plaque psoriasis

A.3.1

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

Clincal study to compare the therapeutic effects of two ointments with active substances betamethasone dipropionate and salicylic acid and of one ointment without active substance for patients with chronic stable plaque psoriasis

A.4.1

Sponsor's protocol code number

20-01/BetaSal-S

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 Research 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	004989641860
B.5.5	Fax number	00498964186110
B.5.6	E-mail	Clinicaltrials.Dermapharm@dermapharm.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	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	Betamethasone dipropionate 0.64 mg/g _Salicylic acid 30 mg/g
D.3.4	Pharmaceutical form	Ointment
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	0.64
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SALICYLIC ACID
D.3.9.1	CAS number	69-72-7
D.3.9.2	Current sponsor code	n.a.
D.3.9.4	EV Substance Code	SUB15180MIG
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	30
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	Diprosalic, pommade
D.2.1.1.2	Name of the Marketing Authorisation holder	Organon France
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.3.1	Product name	Diprosalic(R) Salbe
D.3.4	Pharmaceutical form	Ointment
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	0.64
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SALICYLIC ACID
D.3.9.1	CAS number	69-72-7
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	Salicylic acid
D.3.9.4	EV Substance Code	SUB15180MIG
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	30
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	Ointment
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

Chronic stable plaque psoriasis

E.1.1.1

Medical condition in easily understood language

Chronic stable plaque psoriasis

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	10050576
E.1.2	Term	Psoriasis vulgaris
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

Evaluation of the efficacy and safety of a new ointment containing 0.64 mg/g Betamethasone dipropionate and 30 mg/g Salicylic acid vs. the originator Diprosalic(R) ointment (Reference) vs. vehicle in patients with chronic stable plaque psoriasis

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
- Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk
- Psoriasis affecting ≤ 10% of the total body surface area (BSA)
- A modified PASI score of ≥ 5 to ≤ 15 at baseline
- 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 and during the study
• Use of topical anti-psoriatic therapy (including topical retinoids, topical corticosteroids, vitamin D analogues, salicylic acid, dithranol, coal tar) within two weeks prior study inclusion
• Known intolerance or hypersensitivity against salicylic acid, betamethasone dipropionate 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 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 manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds and vaccination reactions
• Other inflammatory skin disease in the treatment area that may confound the evaluation of the stable plaque psoriasis (e.g. atopic dermatitis, contact dermatitis, tinea corporis)
• 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)

Primary efficacy endpoint to be analyses is the percent change of a modified Psoriasis Area and Severity Index (mPASI) ("excluding the head") between start of treatment (Visit 1) and end of treatment (EoT, Visit 4)

E.5.1.1

Timepoint(s) of evaluation of this end point

Start of therapy (Visit 1) and end of therapy (Visit 4)

E.5.2

Secondary end point(s)

- Percent change of the total body surface area (BSA) affected by psoriasis between visits.
- Course of the individual Psoriasis activity parameters erythema, desquamation and induration at Visit 0, Visit 1, Visit 2, Visit 3 and Visit 4,
respectively.
- Course of the individual Psoriasis area scores separately for each body part at Visit 0, Visit 1, Visit 2, Visit 3 and Visit 4 respectively.
- Percent change of the modified Psoriasis Area and Severity Index (mPASI) between visits.
- Reduction in modified PASI score of >75% between Visit 1 (Day 0) and Visit 4 (EoT).
- Reduction in modified PASI score of >50% between Visit 1 (Day 0) and Visit 4 (EoT).
- Change of the Investigator`s Global Assessment (IGA) between each visit.
- Change of the Patient`s Psoriasis Global Assessment (PPGA) between each visit.
- Controlled disease (defines as "clear" or "almost clear") according to the IGA at Visit 4.
- Controlled disease (defined as "clear" or "almost clear") according to the PPGA at Visit 4.
- Number and classification of advere events
- Evaluation of tolerability by the investigator and by the patient at Visit 2 - Visit 4
- Hemic and clinical chemistry parameters (haemoglobin, haematocrit, erythrocytes, leukocytes, thrombocytes, sodium, potassium, creatinine,
bilirubin, glucose, sGOT, SGPT, gamma-GT and cortisol) at screening visit (Visit 0) and EoT (Visit 4)
- Change in the serum cortisol level from screening visit (Visit 0) to end of week 3 (EoT; Visit 4)

E.5.2.1

Timepoint(s) of evaluation of this end point

Depends on the secondary endpoint, see E5.2 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

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

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.1.3

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

306

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

2021-11-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-22

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

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