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A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (in summary):

  • Subjects having understood and signed an informed consent form
  • Either sex
  • Age 18 years or above
  • All skin types and any ethnic origin
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk

Exclusion Criteria (in summary):

  • Females who are pregnant, or 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 (ustekinmab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
  • Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation

  • Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation

    • 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 2 weeks prior to randomisation

    • WHO group I-II corticosteroids
    • Topical retinoids
    • Vitamin D analogues
    • Topical immunomodulators (e.g. macrolides)
    • Anthracen derivatives
    • Tar
    • Salicylic acid
    • UVB therapy
  • 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 current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
  • Subjects with known or suspected hypersensitivity to component(s) of the investigational products
  • Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia
  • Subjects with known severe hepatic and/or severe renal insufficiency
  • Subjects with any of the following conditions present on the plaque test areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
  • Subjects with skin manifestations on the plaque test areas in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
  • Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis

Sites / Locations

  • LEO Pharma site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clobetasol propionate plus calcipotriol

Arm Description

Outcomes

Primary Outcome Measures

Total Clinical Score of clinical symptoms

Secondary Outcome Measures

Clinical scores, lesions thickness, NIR spectroscopic measurements

Full Information

First Posted
January 5, 2010
Last Updated
October 24, 2013
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01043224
Brief Title
A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris
Official Title
A Psoriasis Plaque Study Comparing Clobetasol Propionate Plus Calcipotriol Ointment With Clobetasol Propionate Ointment Alone, Calcipotriol Ointment Alone and a Vehicle Control for the Treatment of Psoriasis Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial is to compare the anti-psoriatic effect of a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the single components in the same vehicle using a psoriasis plaque test design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clobetasol propionate plus calcipotriol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Combination of clobetasol propionate plus calcipotriol ointment, clobetasol propionate ointment, calcipotriol ointment, and the ointment vehicle
Intervention Description
Once daily application
Primary Outcome Measure Information:
Title
Total Clinical Score of clinical symptoms
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Clinical scores, lesions thickness, NIR spectroscopic measurements
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (in summary): Subjects having understood and signed an informed consent form Either sex Age 18 years or above All skin types and any ethnic origin Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk Exclusion Criteria (in summary): Females who are pregnant, or 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 (ustekinmab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation 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 2 weeks prior to randomisation WHO group I-II corticosteroids Topical retinoids Vitamin D analogues Topical immunomodulators (e.g. macrolides) Anthracen derivatives Tar Salicylic acid UVB therapy 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 current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis Subjects with known or suspected hypersensitivity to component(s) of the investigational products Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia Subjects with known severe hepatic and/or severe renal insufficiency Subjects with any of the following conditions present on the plaque test areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin Subjects with skin manifestations on the plaque test areas in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Facy, PhD
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Pharma site
City
Nice
ZIP/Postal Code
06202
Country
France

12. IPD Sharing Statement

Learn more about this trial

A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris

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