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

Psoriasis Clinical Trial

— Left/Right  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180464
• Other study ID #: H 553 000- 1309
• Secondary ID: 2013-003757-22
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2014
• Last updated: June 9, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• LAS41004

• control

Locations

Country	Name	City	State
Germany	Site 1	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Physician's global assessment (PGA)		Days 1, 4, 8, 15, 22 and 29	No
Secondary	Physician's global tolerability assessment (PGTA)		4, 8, 15, 22 and 29	Yes