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A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297166
First Posted: February 16, 2011
Last Update Posted: October 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LEO Pharma
  Purpose
The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and calcipotriol plus LEO 27989 ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Condition Intervention Phase
Psoriasis Vulgaris Drug: LEO 27989 ointment Drug: Calcipotriol plus LEO 27989 ointment Drug: Calcipotriol ointment Drug: Vehicle ointment Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris.

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline. [ Time Frame: 3 weeks ]
    TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)


Secondary Outcome Measures:
  • Clinical sympton scores [ Time Frame: 3 weeks ]

    Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline.

    Change in Total Clinical Score (TCS) at individual visits compared to baseline.


  • Lesion thickness [ Time Frame: 3 weeks ]
    Change in lesion thickness measured by ultrasound at each assessment compared to baseline.

  • Immunohistochemical and histologic scoring of biopsy material [ Time Frame: 3 weeks ]
  • Intra-subject variability [ Time Frame: 3 weeks ]
    The intra-subject variability of changes from baseline to end of treatment of TCS and skin thickness


Enrollment: 25
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEO 27989 ointment Drug: LEO 27989 ointment
once daily application, 3weeks
Drug: Calcipotriol plus LEO 27989 ointment
once daily application, 3weeks
Drug: Calcipotriol ointment
once daily application, 3weeks
Drug: Vehicle ointment
once daily application, 3weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects having understood and signed an informed consent form
  • Age 18 years or above
  • Males, or females of non-child bearing potential
  • All skin types
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk.

Exclusion criteria:

  • Male who are not willing to use a local contraception (such as condom) for the entire duration of the study, and refrain from fathering a child within 3 months following the last study drug application
  • Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
  • Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks /5 half-lives (which-ever is longer) for experimental biological products prior to randomisation and during the study
  • Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the study
  • Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:

    • Potent or very potent (WHO group III-IV) corticosteroids
    • PUVA or Grenz ray therapy
  • Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:

    • WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
    • Topical retinoids
    • Vitamin D analogues
    • Topical immunomodulators (e.g. macrolides)
    • Anthracen derivatives
    • Tar
    • Salicylic acid
    • UVB therapy
  • Subjects using emollients on the target plaques within one week before randomisation and during the study
  • Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the study
  • Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
  • Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia based on medical history
  • Subjects with a positive Hepatitis B, Hepatitis C or HIV test
  • 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 or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
  • Subjects with current participation in any other interventional clinical, based on interview of the subject
  • Subjects with known or suspected hypersensitivity to component(s) of the investigational products
  • History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency).
  • Subjects with a positive Hepatitis B, Hepatitis C or HIV test
  • Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis on the test areas
  • Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
  • Subjects with any contraindication to skin biopsy procedures: e.g., allergy to local anaesthetics, topical antiseptics (chlorhexidine), bleeding tendency, treatment with anticoagulant drugs, history of poor wound healing, and history of vasovagal hypotension or syncope.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297166


Locations
France
CPCAD
Nice, France
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Catherine Queille-Roussel, MD Centre de Pharmacologie Clinique Applique a la Dermatologie
  More Information

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01297166     History of Changes
Other Study ID Numbers: PLQ-006
2010-022663-35
First Submitted: February 3, 2011
First Posted: February 16, 2011
Last Update Posted: October 25, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Calcitriol
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents