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Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis of Scalp

Intervention: Calcipotriol plus betamethasone dipropionate (LEO80185 gel) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Gregor Jemec, MD, Principal Investigator, Affiliation: Roskilde Hospital, Division of Dermatology


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.

Clinical Details

Official title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis

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

Primary outcome: Overall disease severity according to investigator's assessment at week 8

Secondary outcome:

Total sign score at week 8

Score for scaliness, redness and thickness at week 8

Extent of scalp psoriasis at week 8

Overall disease severity according to investigator's assessment at week 2 and 4

Overall disease severity according to patients at week 8

Adverse events

Laboratory data


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain, Quebec G1V 4X7, Canada

Roskilde Hospital, Division of Dermatology, Roskilde 4000, Denmark

HĂ´pital de l'Archet, Service de Dermatologie, Nice 06202, France

Hudlegekontoret, Sandvika 1338, Norway

Hospitais da Universidade de Coimbra, Servico de dermatologia, Coimbra 3000-075, Portugal

Hospital Virgen de la Macarena, Servicio de DermatologĂ­a, Sevilla 41009, Spain

Akademiska Sjukhuset, Hudkliniken, Uppsala 751 85, Sweden

Western Infirmary, Dermatology Department, Glasgow G11 6NT, United Kingdom

Additional Information

Clinical Trials at LEO Pharma

Starting date: November 2004
Last updated: March 25, 2015

Page last updated: August 23, 2015

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