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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: LEO 27989 ointment; Drug: Calcipotriol plus LEO 27989 ointment; Drug: Calcipotriol ointment; Drug: Vehicle ointment

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Nice, France
    • CPCAD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical sympton scores	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.	3 weeks
Lesion thickness	Change in lesion thickness measured by ultrasound at each assessment compared to baseline.	3 weeks
Immunohistochemical and histologic scoring of biopsy material		3 weeks
Intra-subject variability	The intra-subject variability of changes from baseline to end of treatment of TCS and skin thickness	3 weeks

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Catherine Queille-Roussel, MD, Centre de Pharmacologie Clinique Applique a la Dermatologie

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimated): February 16, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Bone Density Conservation Agents; Membrane Transport Modulators; Micronutrients; Vitamins; Vasoconstrictor Agents; Calcium Channel Agonists; Calcipotriene; Calcitriol
• Other Study ID Numbers: PLQ-006; 2010-022663-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO