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:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01297166
First received: February 3, 2011
Last updated: October 24, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)


Secondary Outcome Measures:
  • Clinical sympton scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Change in lesion thickness measured by ultrasound at each assessment compared to baseline.

  • Immunohistochemical and histologic scoring of biopsy material [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Intra-subject variability [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01297166     History of Changes
Other Study ID Numbers: PLQ-006, 2010-022663-35
Study First Received: February 3, 2011
Last Updated: October 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 31, 2014