Efficacy, Tolerability and Safety of LAS41004 Formulations in a Psoriasis Plaque Test

This study has been completed.
Sponsor:
Collaborator:
proDERM GmbH
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT02111499
First received: March 24, 2014
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

Clinical investigation of anti-psoriatic efficacy and atrophy


Condition Intervention Phase
Psoriasis
Drug: LAS41004-IMP1
Drug: LAS41004 IMP2
Drug: LAS41004 IMP3
Drug: LAS41004 IMP4
Drug: LAS41004 IMP6
Drug: LAS41004 IMP5
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Observer-blind Psoriasis Plaque Test to Investigate the Anti-psoriatic Efficacy, Tolerability and Safety (Skin Atrophy) of LAS41004 Formulations in Patients With Mild to Moderate Plaque Psoriasis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the curve, AUC, of the width of the echo-lucent band based on sonography measurements [ Time Frame: day 1 vs day 29 ] [ Designated as safety issue: No ]
    The primary objective is to gain evidence suggesting efficacy of the investigational products in the treatment of plaque-type psoriasis as assessed by the AUC of the width of the echo-lucent band


Secondary Outcome Measures:
  • erythema and induration [ Time Frame: day 1 vs day 29 ] [ Designated as safety issue: No ]
    investigation of the individual scores for erythema and induration

  • local skin tolerability [ Time Frame: every day for 28 days ] [ Designated as safety issue: Yes ]
    Safety investigation of tolerability parameters assessed by a dermatologist

  • atrophy [ Time Frame: day1 vs day 29 ] [ Designated as safety issue: Yes ]
    investigation of skin atrophy assessments on non-lesional test areas

  • assessment of (serious) Adverse Events [ Time Frame: from baseline to day 29 ] [ Designated as safety issue: Yes ]
    Daily record will be performed and - if needed - causality and severity assessed


Enrollment: 18
Study Start Date: March 2014
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: formulation 1
topical treatment, once daily for 4 weeks
Drug: LAS41004-IMP1
daily topical application
Other Name: LAS41004-IMP1
Drug: LAS41004 IMP2
daily topical application
Other Name: LAS41004 IMP2
Drug: LAS41004 IMP3
daily topical application
Other Name: LAS41004 IMP3
Drug: LAS41004 IMP4
daily topical application
Other Name: LAS41004 IMP4
Drug: LAS41004 IMP6
daily topical application
Other Name: LAS41004 IMP6
Drug: LAS41004 IMP5
once daily, topical
Other Name: LAS41004 IMP5
Experimental: formulation 2
topical treatment, once daily for 4 weeks
Drug: LAS41004-IMP1
daily topical application
Other Name: LAS41004-IMP1
Drug: LAS41004 IMP2
daily topical application
Other Name: LAS41004 IMP2
Drug: LAS41004 IMP3
daily topical application
Other Name: LAS41004 IMP3
Drug: LAS41004 IMP4
daily topical application
Other Name: LAS41004 IMP4
Drug: LAS41004 IMP6
daily topical application
Other Name: LAS41004 IMP6
Drug: LAS41004 IMP5
once daily, topical
Other Name: LAS41004 IMP5
Experimental: formulation 3
topical treatment, once daily for 4 weeks
Drug: LAS41004-IMP1
daily topical application
Other Name: LAS41004-IMP1
Drug: LAS41004 IMP2
daily topical application
Other Name: LAS41004 IMP2
Drug: LAS41004 IMP3
daily topical application
Other Name: LAS41004 IMP3
Drug: LAS41004 IMP4
daily topical application
Other Name: LAS41004 IMP4
Drug: LAS41004 IMP6
daily topical application
Other Name: LAS41004 IMP6
Drug: LAS41004 IMP5
once daily, topical
Other Name: LAS41004 IMP5
Experimental: formulation 4
topical treatment,once daily for 4 weeks
Drug: LAS41004-IMP1
daily topical application
Other Name: LAS41004-IMP1
Drug: LAS41004 IMP2
daily topical application
Other Name: LAS41004 IMP2
Drug: LAS41004 IMP3
daily topical application
Other Name: LAS41004 IMP3
Drug: LAS41004 IMP4
daily topical application
Other Name: LAS41004 IMP4
Drug: LAS41004 IMP6
daily topical application
Other Name: LAS41004 IMP6
Drug: LAS41004 IMP5
once daily, topical
Other Name: LAS41004 IMP5
Placebo Comparator: formulation 5
topical treatment, once daily for 4 weeks
Drug: LAS41004-IMP1
daily topical application
Other Name: LAS41004-IMP1
Drug: LAS41004 IMP2
daily topical application
Other Name: LAS41004 IMP2
Drug: LAS41004 IMP3
daily topical application
Other Name: LAS41004 IMP3
Drug: LAS41004 IMP4
daily topical application
Other Name: LAS41004 IMP4
Drug: LAS41004 IMP6
daily topical application
Other Name: LAS41004 IMP6
Drug: LAS41004 IMP5
once daily, topical
Other Name: LAS41004 IMP5
Active Comparator: formulation 6
topical treatment, once daily for 4 weeks
Drug: LAS41004-IMP1
daily topical application
Other Name: LAS41004-IMP1
Drug: LAS41004 IMP2
daily topical application
Other Name: LAS41004 IMP2
Drug: LAS41004 IMP3
daily topical application
Other Name: LAS41004 IMP3
Drug: LAS41004 IMP4
daily topical application
Other Name: LAS41004 IMP4
Drug: LAS41004 IMP6
daily topical application
Other Name: LAS41004 IMP6
Drug: LAS41004 IMP5
once daily, topical
Other Name: LAS41004 IMP5

Detailed Description:

In this trial three concentrations of bexarotene in combination with a fixed concentration of betamethasone dipropionate, as well as monotherapy with bexarotene, will be investigated regarding their efficacy, tolerability and safety in patients with mild to moderate plaque psoriasis and will be compared with the vehicle and an active comparator.

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

  Eligibility

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

Main Inclusion Criteria:

  • 18 to 75 years of age
  • 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.

Main Exclusion Criteria:

  • • Patients who need systemic treatment for their psoriasis.

    • 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

  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: NCT02111499

Locations
Germany
proDERM GmbH
Schenefeld, Schleswig-Holstein, Germany, 22869
Sponsors and Collaborators
Almirall, S.A.
proDERM GmbH
Investigators
Principal Investigator: Kirstin Deuble-Bente, Dr med proDERM GmbH
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02111499     History of Changes
Other Study ID Numbers: H553000-1308, 2013-003754-24
Study First Received: March 24, 2014
Last Updated: June 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:
psoriasis plaque test
topical application
atrophy measure

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

ClinicalTrials.gov processed this record on August 26, 2014