## Protocol Section
### Identification Module
**NCT ID:** NCT00216879

**Brief Title:** Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis

**Official Title:** Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel

#### Organization Study ID Info
**ID:** MBL 0407 INT
#### Organization
**Class:** INDUSTRY
**Full Name:** LEO Pharma
### Status Module
#### Completion Date
**Date:** 2006-07

#### Last Update Post Date
**Date:** 2015-03-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-25

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2005-02

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2005-09-22
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-15
**Study First Submit QC Date:** 2005-09-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** LEO Pharma

### Description Module

**Brief Summary:** The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.

### Conditions Module

**Conditions:**

- Psoriasis of Scalp

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 800

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Calcipotriol plus betamethasone dipropionate gel (LEO 80185)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The proportions of patients who experience adverse drug reactions and the proportion of patients who experience adverse events of concern associated with long-term topical corticosteroid use on the scalp during the study

#### Secondary Outcomes

**Measure:** Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
* Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
* Extent of scalp psoriasis involving more than 10% of the total scalp area
* Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity

Exclusion Criteria:

* PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
* UVB therapy anywhere on the patient within 14 days prior to randomisation
* Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
* Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
* Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
* Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
* Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
* Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
* Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
* Known or suspected severe renal insufficiency or severe hepatic disorders
* Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
* Trial subjects should be using an adequate method of contraception

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Moncton

**Country:** Canada

**Facility:** Clinique de Dermatologie

**Zip:** E1C 8X3

**Location 2:**

**City:** Hørsholm

**Country:** Denmark

**Facility:** Hørsholm Hospital, Dermatological Department

**Zip:** 2970

**Location 3:**

**City:** Saint-Etienne

**Country:** France

**Facility:** Hôpital Nord, Service de Dermatologie

**Zip:** 42055

**Location 4:**

**City:** Münster

**Country:** Germany

**Facility:** Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

**Zip:** 48179

**Location 5:**

**City:** Airdrie

**Country:** United Kingdom

**Facility:** Monklands Hospital, Department of Dermatology

**Zip:** ML6 6JS

#### Overall Officials

**Official 1:**

**Affiliation:** Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

**Name:** T A Luger, Dr. med.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017444

- Term: Skin Diseases, Papulosquamous

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14422

- Name: Psoriasis

- Relevance: HIGH

- As Found: Psoriasis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19713

- Name: Skin Diseases, Papulosquamous

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011565

- Term: Psoriasis

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000003879

- Term: Dermatologic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4909

- Name: Betamethasone

- Relevance: HIGH

- As Found: 1/2

- ID: M350710

- Name: Calcipotriene

- Relevance: HIGH

- As Found: Grip

- ID: M4910

- Name: Betamethasone Valerate

- Relevance: HIGH

- As Found: Brain Imaging

- ID: M229285

- Name: Betamethasone-17,21-dipropionate

- Relevance: HIGH

- As Found: Brain Imaging

- ID: M259190

- Name: Betamethasone benzoate

- Relevance: HIGH

- As Found: Brain Imaging

- ID: M248787

- Name: Betamethasone sodium phosphate

- Relevance: HIGH

- As Found: Brain Imaging

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001623

- Term: Betamethasone

- ID: D000001624

- Term: Betamethasone Valerate

- ID: C000011175

- Term: Betamethasone-17,21-dipropionate

- ID: C000015706

- Term: Betamethasone benzoate

- ID: C000055085

- Term: Calcipotriene

- ID: C000028994

- Term: Betamethasone sodium phosphate

### Misc Info Module

- Version Holder: 2024-05-24
