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
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.
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 8Score 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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