Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00764751
First received: October 1, 2008
Last updated: October 18, 2013
Last verified: April 2009
  Purpose

This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the body and either Dovonex® cream or cream vehicle to lesions on the other side.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: LEO 19123 Cream (calcipotriol plus LEO 80122)
Drug: Dovonex® cream
Drug: Cream vehicle
Phase 2

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: LEO 19123 Cream in the Treatment of Psoriasis Vulgaris

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • The percentage change in PASI (Psoriasis Area Severity Index) from baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's global assessment of disease severity [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Patient's overall assessment of treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Subject's assessment of treatment preference [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Subjects with "controlled disease" according to the Investigator's global assessment of disease severity [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Subjects with "treatment success" according to the Patient's overall assessment of treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Subjects with at least 75% reduction in PASI (PASI 75) from baseline [ Time Frame: Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
  • Subjects with at least 50% reduction in PASI (PASI 50) from baseline [ Time Frame: Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
  • The absolute change in PASI from baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Subject's mean redness score [ Time Frame: Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
  • Subject's mean scaliness score [ Time Frame: Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]
  • Subject's mean thickness score [ Time Frame: Week 1, Week 2, Week 4 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: LEO 19123 Cream (calcipotriol plus LEO 80122)
Once daily application
Active Comparator: 2 Drug: Dovonex® cream
Twice daily application
Placebo Comparator: 3 Drug: Cream vehicle
Twice 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 washout.
  • Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs with a symmetrical distribution amenable to treatment with a maximum of 50 g/week of topical medication on each side of the body. At Visit 1, there should not be a difference between the right and left side of more than 1 for each of the PASI criteria (redness, thickness and scaliness).
  • A minimum PASI score for extent of 2 on each side in at least one body region (i.e. psoriasis affecting at least 10% of left and right arm, and/or 10% of left and right side of the trunk, and/or 10% of left and right leg).
  • Disease severity graded mild, moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity on each side of the body. The assessment should be the same for both sides of the body.
  • Age 18 years or above
  • Male subjects, or females of non-childbearing potential (i.e. surgically sterile or at least two years postmenopausal)
  • Attending a hospital outpatient clinic or the private practice of a dermatologist

Exclusion Criteria:

  • Subjects using systemic treatments with biological therapies with a possible effect on psoriasis vulgaris within 12 weeks prior to randomisation (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab)
  • Systemic treatment with all other therapies, besides biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation (inhaled or intranasal steroids for asthma or rhinitis may be used)
  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation
  • UVB therapy within 2 weeks prior to randomisation
  • Any topical treatment (except for emollients) of the trunk/limbs (except on flexures) 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, vitamin D analogues or retinoids 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, vitamin D analogues or retinoids 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) within 2 weeks prior to randomisation
  • 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
  • Subjects with current participation in any other interventional clinical trial
  • Subjects with any of the following conditions present on the treatment area: eczematous skin, atopic dermatitis, clinical infection, ulcers and wounds
  • Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investigational products or formulations being tested
  • Subjects with positive hepatitis B, C or HIV
  • Known or suspected severe renal insufficiency or severe hepatic disorders
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia
  • Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
  • Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light should be avoided)
  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: NCT00764751

Locations
Canada, Ontario
UltraNova Skincare
Barrie, Ontario, Canada, L4M 6L2
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Rodion Kunynetz, MD UltraNova Skincare
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00764751     History of Changes
Other Study ID Numbers: LEO 19123-C24
Study First Received: October 1, 2008
Last Updated: October 18, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014