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

Sponsor

Almirall, S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT02180464

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: LAS41004 Drug: control	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LAS41004 Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily	Drug: LAS41004 Drug: control
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: LAS41004 Drug: control

Arm

Intervention/Treatment

Experimental: LAS41004

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

Drug: LAS41004

Drug: control

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: LAS41004

Drug: control

Outcome Measures

Primary Outcome Measures

Total symptom score [day 28 vs baseline]
The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration

Secondary Outcome Measures

Total symtom score (during study performance) [Days 4, 8, 15, and 22]
Change from baseline in the TSS of each treated plaque on 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 1	Hamburg		Germany

Sponsors and Collaborators

Almirall, S.A.

Investigators

Principal Investigator: Walter Wigger-Alberti, Dr med, bioskin, Hamburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Almirall, S.A.

ClinicalTrials.gov Identifier:

NCT02180464

Other Study ID Numbers:

H 553 000- 1309
2013-003757-22

First Posted:

Jul 2, 2014

Last Update Posted:

Jun 10, 2015

Last Verified:

Jun 1, 2015

Keywords provided by Almirall, S.A.

psoriasis, topical

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of Jun 10, 2015