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Completed

NCT Number: NCT02180464

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 1

Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

LAS41004

Drug

Control

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study 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

Acronym: Left/Right

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2014
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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