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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: LAS41004

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany, 22869
    • Investigational Site

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

7

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease of skin thickness(AUC, area under the curve)	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.	day 1 to day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in scaling	scoring of scaling (score 0-4) will be performed by investigator	baseline vs day 22
decrease in erythema	scoring of erythema (score 0-4) wil be performed by investigator	baseline vs day 22
decrease of induration	scoring of induration (score 0-4) will be performed by investigator	baseline vs day 22
assessment of (s)AE	a daily record will be performed and if needed the severity and causality assessed	from baseline to day 22

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: proDERM GmbH

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (ESTIMATE): October 31, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2011
• Last Update Submitted That Met QC Criteria: October 28, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Psoriasis Plaque Test; topical; ointment
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: H553000-1101; 2011-001384-45 (EUDRACT_NUMBER)