Exploratory Study to Investigate Efficacy of LAS41004 in a Psoriasis Plaque Test

NCT01360944 | Completed Phase 2

• 2 other identifiers: H553000-10062011-000186-13
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT).

Conditions

Psoriasis

Keywords

PPT, topical, psoriasis

Outcome Measures

Primary Outcomes (1)

• Decrease in thickness of infiltration

  measurement will be performed by ultrasound, comparing data from baseline (day1) vs end of trial (day15)

  Day 1 (baseline) vs day 15 day (final)

Secondary Outcomes (4)

• Change in clinical score

  day 1 (baseline) vs day 15 (final)

• Change in erythema score

  day1 (baseline) vs day 15 (final)

• Change in Induration score

  day 1 (baseline) vs day 15 (final)

• Change in Scaling score

  day 1 (baseline) vs day 15 (final)

Study Arms (8)

LAS 41004, variant 1, once daily

EXPERIMENTAL

variant 1, once daily

Drug: LAS41004

LAS41004, variant 2, once daily

EXPERIMENTAL

variant 2, once daily

Drug: LAS41004

LAS41004, variant 3, once daily

EXPERIMENTAL

variant 3, once daily

Drug: LAS41004

LAS41004, variant 4, once daily

EXPERIMENTAL

variant 4, once daily

Drug: LAS41004

LAS41004, variant 5, once daily

EXPERIMENTAL

variant 5, once daily

Drug: LAS41004

LAS41004, variant 6, once daily

EXPERIMENTAL

variant 6, once daily

Drug: LAS41004

reference

PLACEBO COMPARATOR

once daily, 100microgram

Drug: reference

reference, once daily

ACTIVE COMPARATOR

once daily

Drug: reference

Interventions

LAS41004 DRUG

once daily, topical, 100 microgram

LAS 41004, variant 1, once daily; LAS41004, variant 2, once daily; LAS41004, variant 3, once daily; LAS41004, variant 4, once daily; LAS41004, variant 5, once daily; LAS41004, variant 6, once daily

reference DRUG

once daily, 100 microgram

reference; reference, once daily

Eligibility Criteria

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

You may qualify if:

• Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 12 months
• Psoriatic plaques that are suitable to be defined as target area lesions by the following criteria:
• oPsoriatic plaques must be located on the trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas
• Comparable psoriatic plaques with at least "2" in each score (range 0-4) for the three distinct signs: scaling, erythema and induration
• No more than 3 points difference in total score (= sum of scores for scaling, erythema and induration; Range 0-12) of the chosen comparable psoriatic plaques
• Enough surface area to the psoriatic plaque to define eight clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² size - Effective contraceptive methods for the duration of the study and for the 4 weeks after study drug discontinuation, for a patient of childbearing potential.

You may not qualify if:

• Any condition that may interfere with the study assessments or ultrasound measurements of the skin and/or may have an influence on the skin immune response (incl. open wounds)
• Current diagnosis of guttate, erythrodermic or pustular psoriasis
• Patients who have received any topical anti-psoriatic drug in the test area within the last 2 weeks before treatment with the IMP.
• Patients who have received topical products in the test area containing DEET (N,N-diethyl-m-polyamide), a common component of insect repellent products within 1 week before treatment with the IMP.
• Patients who have received systemic biologics within the last 6 months before treatment with the IMP or any systemic antipsoriatic treatment (corticosteroids, ciclosporin, methotrexate, fumaric acid esters, acitretin etc)within the last 3 months before treatment with the IMP.
• Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), including but not limited to: skin disease due to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, skin atrophy, striae distensae, increased fragility of skin blood vessels, ichthyosis, ulcers, wounds and reaction after vaccination
• Significant skin infections (including but not limited to: herpes, varicella, mycotic skin infections, bacterial skin infections or parasitic skin infections)
• Excessive sunlight exposure within 28 days prior to study entry and during the conduct of the study
• Usage of any topical formulation (incl. cosmetics, emollients, etc) on the designated target areas during the course of the study
• Vitamin A intake \> 15,000 IU/day

Sponsors & Collaborators

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

Study Sites (1)

Investigational site

Mahlow, Germany

Location

MeSH Terms

Conditions

Psoriasis; Ceroid lipofuscinosis, neuronal 1, infantile

Condition Hierarchy (Ancestors)

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

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: May 24, 2011
• First Posted: May 26, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

DE (1)