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

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

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).

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;