Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris

NCT00670241 | Completed Phase 3 Results

• 1 other identifier: LEO 80185-G21
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8

  Week 8

Secondary Outcomes (4)

• Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4

  Week 4

• The Percentage Change in PASI From Baseline to Week 8

  Baseline, Week 4 and 8

• Subjects With Relapse During the Study

  Week 8-16

• Subjects With Rebound During the Study

  Week 8-16

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: calcipotriol and betamethasone (LEO 80185 gel)

2

ACTIVE COMPARATOR

Drug: Tacalcitol ointment

3

PLACEBO COMPARATOR

Drug: LEO 80185 vehicle

Interventions

calcipotriol and betamethasone (LEO 80185 gel) DRUG

Once daily application

1

LEO 80185 vehicle DRUG

Once daily application

3

Tacalcitol ointment DRUG

Once daily application

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Eastern Canada Cutaneous Research Associates Ltd.

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Interventions

calcipotriene; Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Anders Rhod Larsen, Scientific Advisor
• Organization: LEO Pharma

anders.larsen@leo-pharma.com

+4572262990

Study Officials

• Richard Langley, MD

  Eastern Canada Cutaneous Research Associates Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 10, 2025
• Results First Posted: March 8, 2011

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)