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

This study has been completed.
Sponsor:
Collaborator:
proDERM GmbH
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01462643
First received: October 4, 2011
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: LAS41004
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Decrease of skin thickness(AUC, area under the curve) [ Time Frame: day 1 to day 22 ] [ Designated as safety issue: No ]
    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:
  • Decrease in scaling [ Time Frame: baseline vs day 22 ] [ Designated as safety issue: No ]
    scoring of scaling (score 0-4) will be performed by investigator

  • decrease in erythema [ Time Frame: baseline vs day 22 ] [ Designated as safety issue: No ]
    scoring of erythema (score 0-4) wil be performed by investigator

  • decrease of induration [ Time Frame: baseline vs day 22 ] [ Designated as safety issue: No ]
    scoring of induration (score 0-4) will be performed by investigator

  • assessment of (s)AE [ Time Frame: from baseline to day 22 ] [ Designated as safety issue: Yes ]
    a daily record will be performed and if needed the severity and causality assessed


Enrollment: 22
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: variant1
topical ointment, once daily application
Drug: LAS41004
once daily, topical ointment, 100 microgram per day
Other Name: 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 Name: 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 Name: fixed combinations of retinoid and steroid
Experimental: variant4
topical ointment, once daily application
Drug: LAS41004
once daily, topical ointment, 100 microgram per day
Other Name: 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 Name: 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 Name: 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 Name: fixed combinations of retinoid and steroid

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01462643

Locations
Germany
Investigational site
Schenefeld, Germany, 22869
Sponsors and Collaborators
Almirall, S.A.
proDERM GmbH
Investigators
Study Director: Christoph Willers, MD Almirall Hermal
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01462643     History of Changes
Other Study ID Numbers: H553000-1101, 2011-001384-45
Study First Received: October 4, 2011
Last Updated: October 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:
Psoriasis Plaque Test
topical
ointment

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014