Psoriasis
Conditions
Interventions
This is a randomized, double-blind, controlled clinical trial with two phases. The first phase is a pilot study of the proof-of-concept type, with a randomized, double-blind, split-body design, and pl
Sponsors
Universidade Estadual do Oeste no Paraná (UNIOESTE)
Universidade Estadual do Oeste no Paraná (UNIOESTE)
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Eligibility criteria for participation in the study include: adult individuals of both sexes; age between 18 and 60 years; clinical diagnosis of palmoplantar non-pustular psoriasis and active lesions at the time of inclusion; presence or history (documented by a dermatologist) of at least one additional plaque of psoriasis in another region of the body; a washout period of at least two weeks from the use of other topical medications that could affect psoriasis
Exclusion criteria
Exclusion criteria: The following participants will be excluded: patients with pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis; evidence of other skin diseases that could affect the assessment of palmoplantar non-pustular psoriasis or the response to treatment; pregnant women; breastfeeding women; individuals with a known sensitivity to JAK inhibitors or to the vehicle/placebo; individuals using systemic JAK inhibitors; evidence of latent, active, or inadequately treated tuberculosis; hepatitis B or C infection; HIV (Human Immunodeficiency Virus) infection; history of disseminated or recurrent herpes zoster; history of infection requiring hospitalization or treatment with oral or topical antimicrobials within 2 weeks before baseline; history of lymphoproliferative disorders or malignancies (except for excised basal cell carcinoma or squamous cell carcinoma); history of thrombophilia; individuals using potent or moderate CYP3A4 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find, in both the first and second phases of the study, an improvement of at least 50% in the severity of palmoplantar non-pustular psoriasis lesions with the use of tofacitinib 2% ointment, measured by the score m-PPPASI (Modified Palmoplantar Pustular Psoriasis Area and Severity Index), with the evaluation being conducted by trained dermatologists who will compare pre- and post-intervention data | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the reduction in the severity of non-pustular palmoplantar psoriasis lesions treated with 2% tofacitinib ointment, measured by the hf-PGA (Physician's Global Assessment of the hands and/or feet), comparing pre- and post-intervention data;Evaluate the improvement in the quality of life of patients with non-pustular palmoplantar psoriasis treated with 2% tofacitinib ointment, measured by the DLQI (Dermatology Life Quality Index) and PPQLI (Palmar-Plantar Quality-of-Life Index), comparing pre- and post-intervention data;Evaluate the reduction of pruritus in lesions of non-pustular palmoplantar psoriasis treated with 2% tofacitinib ointment, measured by the VAS (Visual Analog Scale), comparing pre- and post-intervention data;Evaluate the reduction in the severity of nail lesions in patients with non-pustular palmoplantar psoriasis treated with 2% tofacitinib ointment, assessed by the NAPSI (Nail Psoriasis Severity Index), comparing pre- and post-intervention data | — |
Countries
Brazil
Contacts
Public ContactPaula Sakiyama
Universidade Estadual do Oeste no Paraná (UNIOESTE)
Outcome results
None listed