LEO 90100 in the Treatment of Psoriasis Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01536938
First received: February 16, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone are effective in the treatment of psoriasis vulgaris.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: LEO 90100
Drug: Calcipotriol
Drug: Betamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Investigator's global assessment of disease severity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: May 2012
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Calcipotriol
-
Drug: Calcipotriol
Active Comparator: Betamethasone
-
Drug: Betamethasone
Experimental: LEO 90100
-
Drug: LEO 90100

  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 obtained prior to any trial related activities (including washout period).
  • Age 18 years or above
  • Either sex
  • Any race or ethnicity
  • All skin types
  • Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
  • Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
  • Able to communicate with the investigator and understand and comply with the requirements of the study.

Exclusion Criteria:

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

    • etanercept - within 4 weeks prior to randomisation
    • adalimumab, alefacept, infliximab - within 8 weeks prior to randomisation
    • ustekinumab - within 16 weeks prior to randomisation
    • other products - 4 weeks/5 half-lives (whichever is longer)
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
  • Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
  • PUVA therapy within 4 weeks prior to randomisation.
  • UVB therapy within 2 weeks prior to randomisation.
  • Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study.
  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study.
  • Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds.
  • Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.
  • 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.
  • Previously randomised in this study.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536938

  Show 33 Study Locations
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Mark Lebwohl, M.D. Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01536938     History of Changes
Other Study ID Numbers: LEO 90100-7
Study First Received: February 16, 2012
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014