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 has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00670241
First received: April 29, 2008
Last updated: October 21, 2013
Last verified: February 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 8 [ Time Frame: Baseline, Week 4 and 8 ] [ Designated as safety issue: No ]
    PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).

  • Subjects With Relapse During the Study [ Time Frame: Week 8-16 ] [ Designated as safety issue: No ]
    Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit

  • Subjects With Rebound During the Study [ Time Frame: Week 8-16 ] [ Designated as safety issue: Yes ]

Enrollment: 458
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: calcipotriol and betamethasone (LEO 80185 gel)
Once daily application
Active Comparator: 2 Drug: Tacalcitol ointment
Once daily application
Placebo Comparator: 3 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670241

Locations
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada, B3H 1Z4
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Richard Langley, MD Eastern Canada Cutaneous Research Associates Ltd.
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00670241     History of Changes
Other Study ID Numbers: LEO 80185-G21
Study First Received: April 29, 2008
Results First Received: November 23, 2010
Last Updated: October 21, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone benzoate
1 alpha,24-dihydroxyvitamin D3
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014