DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris

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

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Colin Fleming, MD, Principal Investigator, Affiliation: Ninewells Hospital and Medical School, Ninewells, Dundee, UK

Summary

The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks. The primary response criterion is the number of patients with controlled disease at week 8.

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 Psoriasis Vulgaris

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" (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8.

Secondary outcome:

The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8.

Patients with "controlled disease" according to the investigators' global assessment of disease severity at week 1, 2, and 6.

Patients with "clear" or "very mild" disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8.

Eligibility

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

Criteria:

Inclusion Criteria:

- Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with

a maximum of 100 g of topical medication per week

- An investigators' global assessment of disease severity of at least mild

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 psoriasis

vulgaris within 6 months prior to randomisation

- Systemic treatment with all other therapies than biologicals, with a possible effect

on psoriasis vulgaris (e. g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation

- Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior

to randomisation

- Topical treatment for other relevant skin disorders (except WHO group I-II

corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation

- Planned initiation of, or changes to concomitant medication that could affect

psoriasis vulgaris (e. g., beta blockers, anti-malaria drugs, lithium) during the study

- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Locations and Contacts

Universitätsklinikum Leipzig, Leipzig 04103, Germany

Waterford Regional Hospital, Waterford, Ireland

Läkarhuset Vällingby, Vällingby 16268, Sweden

The Guenther Dermatology Research Centre, London, Ontario N6A3H7, Canada

Ninewells Hospital and Medical School, Dundee, Scotland DD1 9SY, United Kingdom

Additional Information

Clinical Trials at LEO Pharma

Starting date: December 2005
Last updated: March 25, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017