Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris
This study is currently recruiting participants.
Verified by LEO Pharma, November 2008
Sponsored by: LEO Pharma
Information provided by: LEO Pharma
ClinicalTrials.gov Identifier: NCT00670241
  Purpose

This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).


Condition Intervention Phase
Psoriasis Vulgaris
Drug: calcipotriol and betamethasone (LEO 80185 gel)
Drug: LEO 80185 vehicle
Drug: Tacalcitol ointment
Phase III

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcipotriene Betamethasone Bentelan Betamethasone dipropionate Tacalcitol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 Mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Subjects with "Controlled disease" ("Clear" or "Almost Clear" disease) according to Investigator's global assessment of disease severity at week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects with "controlled disease" according to the Investigator's global assessment of disease severity at week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • The percentage change in PASI from baseline to week 4 and 8 [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  • Subjects with relapse during the study and time to relapse [ Time Frame: Week 8-16 ] [ Designated as safety issue: No ]
  • Subjects with rebound during the study [ Time Frame: Week 8-16 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: April 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: calcipotriol and betamethasone (LEO 80185 gel)
Once daily application
2: Active Comparator Drug: Tacalcitol ointment
Once daily application
3: Placebo Comparator Drug: LEO 80185 vehicle
Once daily application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent to be obtained prior to any trial related procedure, including wash-out
  • Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of LEO 80185 gel per week or 10 g per day of tacalcitol ointment
  • Disease severity graded moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity
  • A minimum PASI score for extent of 2 in at least one body region (i.e.psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
  • Subjects aged 18 years or above
  • Either sex
  • Any ethnic origin
  • Attending hospital outpatient clinic or the private practice of a dermatologist

Exclusion Criteria:

  • Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
  • Systemic treatment with all other therapies than biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation
  • Systemic treatment with Vitamin D preparations above 500 IU per day
  • PUVA or Grenz ray therapy within 4 weeks prior to randomization
  • UVB therapy within 2 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 on the face and flexures (e.g., facial and flexural psoriasis, eczema) with potent or very potent (WHO group III-IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
  • Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with very potent (WHO group IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
  • Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) during the study
  • Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
  • Subjects with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atro-phicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia
  • Known or suspected severe renal insufficiency or severe hepatic disorders
  • Known or suspected hypersensitivity to component(s) of the Investigational Products
  • Current participation in any other interventional clinical study
  • Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation, except for biologics (3 months)
  • Planned exposure to sun during the study that may affect psoriasis vulgaris
  • Previously randomised to this study
  • Subjects known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychotic state)
  • Females of child-bearing potential wishing to become pregnant during the study, or are breast-feeding, or not using an adequate method of contraception during the study
  • Females of child-bearing potential with positive pregnancy test at Visit 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670241

Contacts
Contact: Dusica Curcic, Ph.D 905-747-2354 Dusica.curcic@leo-pharma.com
Contact: Vibeke Hoffmann, MSc Pharm 45-4494-5888 vibeke.hoffmann@leo-pharma.com

Locations
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd. Recruiting
Halifax, Nova Scotia, Canada, B3H 1Z4
Contact: Richard Langley, MD     902-423-0482     richard.langley@dal.ca    
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Richard Langley, MD Eastern Canada Cutaneous Research Associates Ltd.
  More Information

Responsible Party: LEO Pharma INC. ( Dusica Curcic, Clinical Project Manager )
Study ID Numbers: LEO 80185-G21
Study First Received: April 29, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00670241  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Calcipotriene
Betamethasone-17,21-dipropionate
Sodium phosphate
Skin Diseases
Psoriasis
Betamethasone sodium phosphate
1 alpha,24-dihydroxyvitamin D3
Dihydroxycholecalciferols
Betamethasone
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Dermatologic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009