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

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ClinicalTrials.gov Identifier: NCT02180464
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.

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 Type : Interventional  (Clinical Trial)
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 : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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



Primary Outcome Measures :
  1. Total symptom score [ Time Frame: 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 :
  1. Total symtom score (during study performance) [ Time Frame: Days 4, 8, 15, and 22 ]
    Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22

  2. Physician's global assessment (PGA) [ Time Frame: Days 1, 4, 8, 15, 22 and 29 ]
  3. Physician's global tolerability assessment (PGTA) [ Time Frame: 4, 8, 15, 22 and 29 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180464


Locations
Germany
Site 1
Hamburg, Germany
Sponsors and Collaborators
Almirall, S.A.
Investigators
Principal Investigator: Walter Wigger-Alberti, Dr med bioskin, Hamburg

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02180464     History of Changes
Other Study ID Numbers: H 553 000- 1309
2013-003757-22 ( EudraCT Number )
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Almirall, S.A.:
psoriasis, topical

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases