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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

Page last updated: August 23, 2015

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