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

Almirall

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: LAS41004; Drug: control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02180464

H 553 000- 1309

2013-003757-22 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

LAS41004

Experimental group

Description:

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

Treatment:

Drug: LAS41004

Drug: control

control

Active Comparator group

Description:

Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily

Treatment:

Drug: LAS41004

Drug: control