A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis

NCT ID: NCT02180464

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

Brief Summary

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).

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LAS41004

Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily

Group Type: EXPERIMENTAL

LAS41004

Intervention Type: DRUG

control

Intervention Type: DRUG

control

Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily

Group Type: ACTIVE_COMPARATOR

LAS41004

Intervention Type: DRUG

control

Intervention Type: DRUG

Interventions

LAS41004

Intervention Type: DRUG

control

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Wigger-Alberti, Dr med

Role: PRINCIPAL_INVESTIGATOR

bioskin, Hamburg

Locations

Site 1

Hamburg, , Germany

Countries

Germany

Other Identifiers

2013-003757-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H 553 000- 1309

Identifier Type: -

Identifier Source: org_study_id