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

NCT01462643 | Completed Phase 2

• 2 other identifiers: H553000-11012011-001384-45
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Keywords

Psoriasis Plaque Test; topical; ointment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Decrease in scaling

  baseline vs day 22

• decrease in erythema

  baseline vs day 22

• decrease of induration

  baseline vs day 22

• assessment of (s)AE

  from baseline to day 22

Study Arms (7)

variant1

EXPERIMENTAL

topical ointment, once daily application

Drug: LAS41004

variant 2

EXPERIMENTAL

topical ointment, once daily application

Drug: LAS41004

variant 3

EXPERIMENTAL

topical ointment, once daily application

Drug: LAS41004

variant4

EXPERIMENTAL

topical ointment, once daily application

Drug: LAS41004

variant 5

EXPERIMENTAL

topical ointment, once daily application

Drug: LAS41004

variant 6

PLACEBO COMPARATOR

topical ointment, once daily application

Drug: LAS41004

control positive

ACTIVE COMPARATOR

topical ointment,once daily application

Drug: LAS41004

Interventions

LAS41004 DRUG

once daily, topical ointment, 100 microgram per day

Also known as: fixed combinations of retinoid and steroid

control positive; variant 2; variant 3; variant 5; variant 6; variant1; variant4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• located at trunk and/or extremities (plaques located on the head, palms, or sole of feet, intertriginous or genitoanal areas are not suitable)
• 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.
• No more than 3 points difference in total score (sum of scores for scaling, erythema and induration)
• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Almirall, S.A.: lead
• proDERM GmbH: collaborator

Study Sites (1)

Investigational site

Schenefeld, 22869, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Christoph Willers, MD

  Almirall Hermal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 31, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 31, 2011

Record last verified: 2011-10

Locations

DE (1)