A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis (Left/Right)

A Phase IIa, 28-day Treatment, Multi-center, Randomized, Comparator-controlled, Observer-blind Trial With Intra-individual Left/Right Comparison to Investigate the Anti-psoriatic Efficacy and the Safety of an LAS41004 Formulation in Comparison to an Active Reference in Patients With Mild to Moderate Plaque Psoriasis

Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Site 1

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria (main):

• mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6;

  • female volunteers of childbearing potential* must agree to use appropriate and reliable methods of contraception
  • written informed consent obtained.

Exclusion Criteria (main):

• severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
• treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
• treatment with any systemic medications which might counter or influence the trial aim or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
• treatment with vitamin A supplements;
• treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
• treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial;
• known allergic reactions, irritations or hypersensitivity to the active ingredients
• contraindications according to summary of product characteristics (SmPC) of the active comparator: - pregnancy or nursing;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAS41004; Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily	Drug: control; Drug: LAS41004
Active Comparator: control; Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily	Drug: control; Drug: LAS41004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total symptom score	The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration	day 28 vs baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total symtom score (during study performance)	Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22	Days 4, 8, 15, and 22
Physician's global assessment (PGA)		Days 1, 4, 8, 15, 22 and 29
Physician's global tolerability assessment (PGTA)		4, 8, 15, 22 and 29

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Investigators: Principal Investigator: Walter Wigger-Alberti, Dr med, bioskin, Hamburg

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: psoriasis, topical
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: H 553 000- 1309; 2013-003757-22 (EudraCT Number)