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PPT4: Efficacy and Tolerability of LAS41004 Formulations in a Non-occlusive Psoriasis Plaque Test

Sponsor
Almirall, S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01462643
Collaborator
proDERM GmbH (Industry)
22
Enrollment
1
Location
7
Arms
1
Duration (Months)
21.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the exploratory study is to compare dose related effects of LAS41004 formulations in a non-occlusive PPT.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Going for a non-occlusive application design will allow to draw practical conclusions as being similar to a real treatment situation (compared with a occluded design to maximise effects)

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 22 Day Controlled, Randomized Clinical Study (PPT) Investigating the Anti-psoriatic Efficacy and the Tolerability of an Ointment Containing a Retinoid and a Steroid in Different Concentrations
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: variant1

topical ointment, once daily application

Drug: LAS41004
once daily, topical ointment, 100 microgram per day
Other Names:
  • fixed combinations of retinoid and steroid

    		•
    Experimental: variant 2

    topical ointment, once daily application

    Drug: LAS41004
    once daily, topical ointment, 100 microgram per day
    Other Names:
  • fixed combinations of retinoid and steroid

    		•
    Experimental: variant 3

    topical ointment, once daily application

    Drug: LAS41004
    once daily, topical ointment, 100 microgram per day
    Other Names:
  • fixed combinations of retinoid and steroid

    		•
    Experimental: variant4

    topical ointment, once daily application

    Drug: LAS41004
    once daily, topical ointment, 100 microgram per day
    Other Names:
  • fixed combinations of retinoid and steroid

    		•
    Experimental: variant 5

    topical ointment, once daily application

    Drug: LAS41004
    once daily, topical ointment, 100 microgram per day
    Other Names:
  • fixed combinations of retinoid and steroid

    		•
    Placebo Comparator: variant 6

    topical ointment, once daily application

    Drug: LAS41004
    once daily, topical ointment, 100 microgram per day
    Other Names:
  • fixed combinations of retinoid and steroid

    		•
    Active Comparator: control positive

    topical ointment,once daily application

    Drug: LAS41004
    once daily, topical ointment, 100 microgram per day
    Other Names:
  • fixed combinations of retinoid and steroid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Decrease of skin thickness(AUC, area under the curve) [day 1 to day 22]

      Measurement of skin thickness will be performed by ultrasound (distance between lower border of entry echo and lower border of dermis). The area under the curve, AUC, from day 1 to day 22 will be compared to the reference formulations.

    Secondary Outcome Measures

    1. Decrease in scaling [baseline vs day 22]

      scoring of scaling (score 0-4) will be performed by investigator

    2. decrease in erythema [baseline vs day 22]

      scoring of erythema (score 0-4) wil be performed by investigator

    3. decrease of induration [baseline vs day 22]

      scoring of induration (score 0-4) will be performed by investigator

    4. assessment of (s)AE [from baseline to day 22]

      a daily record will be performed and if needed the severity and causality assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 to 75 years of age

    • Caucasian men and women

    • Suffering from mild to moderate plaque psoriasis of at least 6 months duration that is amenable to local therapy

    • With at least one stable psoriatic plaque in an area sufficient for product application meeting the following criteria:

    1. located at trunk and/or extremities (plaques located on the head, palms, or sole of feet, intertriginous or genitoanal areas are not suitable)

    2. Where more than one plaque is to be used, plaques that are comparable, with at least "2" in each score for scaling, erythema and induration.

    3. No more than 3 points difference in total score (sum of scores for scaling, erythema and induration)

    4. Negative urine pregnancy test (in female patients of child bearing potential)

    • In the case of women of childbearing potential, using reliable methods of contraception which result in a low failure rate i.e. less than 1% per year (eg contraceptive implants or injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner)
    Exclusion Criteria:

    • Patients who need systemic treatment for their psoriasis

    • Severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, including:

    • guttate

    • erythroderma

    • exfoliative or

    • pustular psoriasis

    • psoriatic arthritis

    • Changes in the expression of psoriasis within the last 6 weeks prior screening

    • Intensive UV light exposure within two weeks before the beginning of the test as well as during the study and four weeks after the end of the study at the test area

    • Systemic treatment (see table below):

    Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study Retinoids Ciclosporin Methotrexate Fumaric acid esters 3 months prior to study day 1 and during conduct of study Anti-inflammatory substances, NSAIDs 2 weeks prior to study day 1 and during conduct of study Biologics 6 months prior to study day 1 and during conduct of study Planned initiation of, or changes to concomitant medication that could affect Psoriasis (e.g. beta blockers, anti-malaria drugs, lithium) 8 weeks before study start and during study

    • Topical treatment of all other body regions with corticosteroids or immunosuppressants where more than 20 % of the body surface area is treated

    • Treatment with any non-marketed drug substance within 4 weeks prior to study day 1

    • Topical treatment of the test area without adequate time for washout

    • Diseases:

    Skin infections caused by bacteria, viruses or fungi, including but not limited to tuberculosis, syphilis or varicella zoster infection Parasitic infections Rosacea, perioral dermatitis in test area Moderate or severe illness within the last two weeks before first exposure Other known infectious diseases (e.g. hepatitis or AIDS) Other skin diseases that may confound the evaluation of psoriasis

    • Known hypersensitivity to any ingredients of the study drugs,

    • Known calcium metabolism disorders

    • History of malignancy of any organ system

    • Severe impairment of liver or kidney function

    • Pregnancy or lactation

    • Participation in a clinical trial within the last 30 days prior to the start of this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational site Schenefeld Germany 22869

    Sponsors and Collaborators

    • Almirall, S.A.
    • proDERM GmbH

    Investigators

    • Study Director: Christoph Willers, MD, Almirall Hermal

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Almirall, S.A.
    ClinicalTrials.gov Identifier:
    NCT01462643
    Other Study ID Numbers:
    • H553000-1101
    • 2011-001384-45
    First Posted:
    Oct 31, 2011
    Last Update Posted:
    Oct 31, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Almirall, S.A.
    Psoriasis Plaque Test
    topical
    ointment
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Oct 31, 2011