Psoriasis
Conditions
Keywords
psoriasis, topical
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).
Interventions
DRUGLAS41004
DRUGcontrol
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total symptom score | 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
| Measure | Time frame | Description |
|---|---|---|
| Total symtom score (during study performance) | Days 4, 8, 15, and 22 | Change from baseline in the TSS of each treated plaque on Days 4, 8, 15, and 22 |
| Physician's global assessment (PGA) | Days 1, 4, 8, 15, 22 and 29 | — |
| Physician's global tolerability assessment (PGTA) | 4, 8, 15, 22 and 29 | — |
Countries
Germany
Outcome results
None listed