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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00216827
Other study ID # MBL 0405 INT
Secondary ID
Status Completed
Phase Phase 3
First received September 15, 2005
Last updated March 25, 2015
Start date November 2004
Est. completion date September 2005

Study information

Verified date March 2015
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaDenmark: Danish Medicines AgencySpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Norway: Norwegian Medicines AgencySweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPortugal: National Pharmacy and Medicines InstituteUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.

The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 1485
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Main Inclusion Criteria:

- Scalp psoriasis amenable to topical treatment

- 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 mild or worse by the investigator

- Consenting out-patients of 18 years or above

Main Exclusion Criteria:

- PUVA or Grenz ray therapy within 4 weeks prior to randomisation

- UVB therapy within 2 weeks prior to randomisation

- Systematic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation

- Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation

- Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation

- Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation

- Current diagnosis of erythrodermic, exfoliative or pustular psoriasis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Calcipotriol plus betamethasone dipropionate (LEO80185 gel)


Locations

Country Name City State
Canada FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain Quebec
Denmark Roskilde Hospital, Division of Dermatology Roskilde
France Hôpital de l'Archet, Service de Dermatologie Nice
Norway Hudlegekontoret Sandvika
Portugal Hospitais da Universidade de Coimbra, Servico de dermatologia Coimbra
Spain Hospital Virgen de la Macarena, Servicio de Dermatología Sevilla
Sweden Akademiska Sjukhuset, Hudkliniken Uppsala
United Kingdom Western Infirmary, Dermatology Department Glasgow

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Norway,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall disease severity according to investigator's assessment at week 8
Secondary Total sign score at week 8
Secondary Score for scaliness, redness and thickness at week 8
Secondary Extent of scalp psoriasis at week 8
Secondary Overall disease severity according to investigator's assessment at week 2 and 4
Secondary Overall disease severity according to patients at week 8
Secondary Adverse events
Secondary Laboratory data
See also
  Status Clinical Trial Phase
Completed NCT00243464 - Efficacy of Calcipotriol Plus Betamethasone Gel Versus Calcipotriol Scalp Solution in Scalp Psoriasis Phase 3
Recruiting NCT05144165 - Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines
Completed NCT05105139 - Study to Evaluate the Safety of Sebryl® and Sebryl Plus® in Seborrheic Dermatitis and Psoriasis of Scalp
Recruiting NCT04099979 - A Pilot Study to Explore the Role of Gut Flora in Psoriasis
Not yet recruiting NCT03553433 - Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis Phase 4
Recruiting NCT05938361 - Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis
Recruiting NCT05858632 - Immune Spatial Features of Guselkumab Cutaneous Response Phase 4
Completed NCT00216879 - Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis Phase 3
Completed NCT00216840 - Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Scalp Psoriasis Phase 3

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