Back to resultsA Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis (Left/Right)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
LAS41004
control
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, topical
Eligibility Criteria
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;
Sites / Locations
- Site 1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LAS41004
control
Arm Description
Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily
Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily
Outcomes
Primary Outcome Measures
Total symptom score
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)
Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22
Physician's global assessment (PGA)
Physician's global tolerability assessment (PGTA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02180464
Brief Title
A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, topical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAS41004
Arm Type
Experimental
Arm Description
Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily
Arm Title
control
Arm Type
Active Comparator
Arm Description
Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily
Intervention Type
Drug
Intervention Name(s)
LAS41004
Intervention Type
Drug
Intervention Name(s)
control
Primary Outcome Measure Information:
Title
Total symptom score
Description
The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration
Time Frame
day 28 vs baseline
Secondary Outcome Measure Information:
Title
Total symtom score (during study performance)
Description
Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22
Time Frame
Days 4, 8, 15, and 22
Title
Physician's global assessment (PGA)
Time Frame
Days 1, 4, 8, 15, 22 and 29
Title
Physician's global tolerability assessment (PGTA)
Time Frame
4, 8, 15, 22 and 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Wigger-Alberti, Dr med
Organizational Affiliation
bioskin, Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 1
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis
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