Efficacy, Tolerability and Safety of LAS41004 Formulations in a Psoriasis Plaque Test
NCT ID: NCT02111499
Last Updated: 2014-06-09
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2014-03-31
2014-06-30
Brief Summary
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Detailed Description
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Since a side effect of the application of corticosteroids is skin atrophy, additionally three non-lesional test areas (not affected by psoriasis) on the volar forearm will be treated with the active reference product, one of the fixed combinations and the vehicle. Skin atrophy will be investigated by visual assessment and ultrasound at these test areas
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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formulation 1
topical treatment, once daily for 4 weeks
LAS41004-IMP1
daily topical application
LAS41004 IMP2
daily topical application
LAS41004 IMP3
daily topical application
LAS41004 IMP4
daily topical application
LAS41004 IMP6
daily topical application
LAS41004 IMP5
once daily, topical
formulation 2
topical treatment, once daily for 4 weeks
LAS41004-IMP1
daily topical application
LAS41004 IMP2
daily topical application
LAS41004 IMP3
daily topical application
LAS41004 IMP4
daily topical application
LAS41004 IMP6
daily topical application
LAS41004 IMP5
once daily, topical
formulation 3
topical treatment, once daily for 4 weeks
LAS41004-IMP1
daily topical application
LAS41004 IMP2
daily topical application
LAS41004 IMP3
daily topical application
LAS41004 IMP4
daily topical application
LAS41004 IMP6
daily topical application
LAS41004 IMP5
once daily, topical
formulation 4
topical treatment,once daily for 4 weeks
LAS41004-IMP1
daily topical application
LAS41004 IMP2
daily topical application
LAS41004 IMP3
daily topical application
LAS41004 IMP4
daily topical application
LAS41004 IMP6
daily topical application
LAS41004 IMP5
once daily, topical
formulation 5
topical treatment, once daily for 4 weeks
LAS41004-IMP1
daily topical application
LAS41004 IMP2
daily topical application
LAS41004 IMP3
daily topical application
LAS41004 IMP4
daily topical application
LAS41004 IMP6
daily topical application
LAS41004 IMP5
once daily, topical
formulation 6
topical treatment, once daily for 4 weeks
LAS41004-IMP1
daily topical application
LAS41004 IMP2
daily topical application
LAS41004 IMP3
daily topical application
LAS41004 IMP4
daily topical application
LAS41004 IMP6
daily topical application
LAS41004 IMP5
once daily, topical
Interventions
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LAS41004-IMP1
daily topical application
LAS41004 IMP2
daily topical application
LAS41004 IMP3
daily topical application
LAS41004 IMP4
daily topical application
LAS41004 IMP6
daily topical application
LAS41004 IMP5
once daily, topical
Eligibility Criteria
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Inclusion Criteria
* Men and women with skin type I to IV (Fitzpatrick 1974).
* 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:
* Located at the trunk and/or the extremities (plaques located on the head, palms, or soles of the feet, intertriginous or genitoanal areas are not suitable).
* Plaques with a clinical score of the parameter erythema and or induration of ≥ 2 for each sign at the screening visit. At Day 1 each parameter has to be scored ≥ 2.
* Where more than one plaque is to be used, plaques should be comparable, with at least "2" in each score for erythema and induration.
* • Body surface area (BSA) involvement \< 10 %.
* Prepared to give written informed consent specific to the trial, before any assessment is performed.
* • 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 (e.g. contraceptive implants or injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner). During the study an additional barrier method (e.g. condoms) should be used. Non-childbearing potential is defined as surgical sterilization (hysterectomy, ovariectomy or tubal ligation), postmenopausal status (continuous amenorrhea of at least 2 years).
* In the case of men with partners of childbearing potential willingness of using condoms during the study conduct and 1 month after end of treatment.
Exclusion Criteria
* Severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
* Systemic treatment (see table below):
Corticosteroids, antibiotics 4 weeks prior to trial Day 1 and during conduct of trial Retinoids Ciclosporin Methotrexate Fumaric acid esters 3 months prior to trial Day 1 and during conduct of trial Anti-inflammatory substances, NSAIDs 2 weeks prior to trial Day 1 and during conduct of trial Biologics 6 months prior to trial Day 1 and during conduct of trial
* Topical treatment of all other body regions with corticosteroids or immunosuppressants where more than 20 % of the body surface area is treated.
* Diseases:
Significant skin infections caused by bacteria, viruses or fungi, including but not limited to tuberculosis, syphilis or varicella zoster infection Parasitic infections
18 Years
75 Years
ALL
No
Sponsors
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proDERM GmbH
INDUSTRY
Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Kirstin Deuble-Bente, Dr med
Role: PRINCIPAL_INVESTIGATOR
proDERM GmbH
Locations
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proDERM GmbH
Schenefeld, Schleswig-Holstein, Germany
Countries
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Other Identifiers
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2013-003754-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H553000-1308
Identifier Type: -
Identifier Source: org_study_id
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