Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in 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): Peter van de Kerkhof, MD, Principal Investigator, Affiliation: Universitair Medisch, Afdeling Dermatologie
Summary
The purpose of the study is to evaluate whether once daily topical 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 and
calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.
The primary response criterion is the number of patients with absence of disease and 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 and Calcipotriol in the Gel Vehicle in Scalp Psoriasis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
Secondary outcome: - Total sign score at week 8- Score for scaliness, redness and thickness at week 8 - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4 - Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8 - Evaluation of Adverse Events - Evaluation of Laboratory Data
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Scalp psoriasis amenable to topical treatment with a maximum of 100 g of 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
- Investigator's assessment of clinical signs of the scalp of at least 2 in one of the
clinical signs, erythema, thickness and scaliness, and at least 1 in each of the
other two clinical signs
- Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe
according to the investigator's global assessment of disease severity
Exclusion Criteria:
- PUVA or Grenz ray therapy within 4 weeks prior to randomisation
- UVB therapy within 2 weeks prior to randomisation
- Systemic 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
Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie, Leuven BE-3000, Belgium
Policlinic of Dermatology, Medical Reception Centre, Turku SF-20100, Finland
Hôpital Trousseau, Service de Dermatologie CHU Tours, Tours F-37044, France
Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie, Göttingen D-37075, Germany
Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie, Nijmegen NL-6525, Netherlands
Royal Gwent Hospital, Department of Dermatology, Newport NP20 2UB, United Kingdom
Innovaderm Research Inc., Montreal, Quebec H2K 4L5, Canada
Additional Information
Clinical Trials at LEO Pharma
Starting date: December 2004
Last updated: March 25, 2015
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