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

February 3, 2011
October 24, 2013
February 2011
April 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01297166 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris
A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With Psoriasis Vulgaris.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Psoriasis Vulgaris
  • 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
Experimental: LEO 27989 ointment
Interventions:
  • Drug: LEO 27989 ointment
  • Drug: Calcipotriol plus LEO 27989 ointment
  • Drug: Calcipotriol ointment
  • Drug: Vehicle ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01297166
PLQ-006, 2010-022663-35
No
LEO Pharma
LEO Pharma
Not Provided
Principal Investigator: Catherine Queille-Roussel, MD Centre de Pharmacologie Clinique Applique a la Dermatologie
LEO Pharma
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP