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

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

Clinical investigation of anti-psoriatic efficacy and atrophy

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Schenefeld, Schleswig-Holstein, Germany, 22869
      • proDERM GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: formulation 1; topical treatment, once daily for 4 weeks	Drug: LAS41004-IMP1; daily topical application; Drug: LAS41004 IMP2; daily topical application; Drug: LAS41004 IMP3; daily topical application; Drug: LAS41004 IMP4; daily topical application; Drug: LAS41004 IMP6; daily topical application; Drug: LAS41004 IMP5; once daily, topical
Experimental: formulation 2; topical treatment, once daily for 4 weeks	Drug: LAS41004-IMP1; daily topical application; Drug: LAS41004 IMP2; daily topical application; Drug: LAS41004 IMP3; daily topical application; Drug: LAS41004 IMP4; daily topical application; Drug: LAS41004 IMP6; daily topical application; Drug: LAS41004 IMP5; once daily, topical
Experimental: formulation 3; topical treatment, once daily for 4 weeks	Drug: LAS41004-IMP1; daily topical application; Drug: LAS41004 IMP2; daily topical application; Drug: LAS41004 IMP3; daily topical application; Drug: LAS41004 IMP4; daily topical application; Drug: LAS41004 IMP6; daily topical application; Drug: LAS41004 IMP5; once daily, topical
Experimental: formulation 4; topical treatment,once daily for 4 weeks	Drug: LAS41004-IMP1; daily topical application; Drug: LAS41004 IMP2; daily topical application; Drug: LAS41004 IMP3; daily topical application; Drug: LAS41004 IMP4; daily topical application; Drug: LAS41004 IMP6; daily topical application; Drug: LAS41004 IMP5; once daily, topical
Placebo Comparator: formulation 5; topical treatment, once daily for 4 weeks	Drug: LAS41004-IMP1; daily topical application; Drug: LAS41004 IMP2; daily topical application; Drug: LAS41004 IMP3; daily topical application; Drug: LAS41004 IMP4; daily topical application; Drug: LAS41004 IMP6; daily topical application; Drug: LAS41004 IMP5; once daily, topical
Active Comparator: formulation 6; topical treatment, once daily for 4 weeks	Drug: LAS41004-IMP1; daily topical application; Drug: LAS41004 IMP2; daily topical application; Drug: LAS41004 IMP3; daily topical application; Drug: LAS41004 IMP4; daily topical application; Drug: LAS41004 IMP6; daily topical application; Drug: LAS41004 IMP5; once daily, topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve, AUC, of the width of the echo-lucent band based on sonography measurements	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	day 1 vs day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
erythema and induration	investigation of the individual scores for erythema and induration	day 1 vs day 29
local skin tolerability	Safety investigation of tolerability parameters assessed by a dermatologist	every day for 28 days
atrophy	investigation of skin atrophy assessments on non-lesional test areas	day1 vs day 29
assessment of (serious) Adverse Events	Daily record will be performed and - if needed - causality and severity assessed	from baseline to day 29

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: proDERM GmbH
• Investigators: Principal Investigator: Kirstin Deuble-Bente, Dr med, proDERM GmbH

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Estimate): June 9, 2014
• Last Update Submitted That Met QC Criteria: June 6, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: psoriasis plaque test; topical application; atrophy measure
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: H553000-1308; 2013-003754-24 (EudraCT Number)