Nail Psoriasis
Conditions
Brief summary
To evaluate the efficacy and safety of topical 2% tofacitinib nail lacquer in nail psoriasis, using the NAPSI and DLQI scales before and after 26 weeks of treatment.
Interventions
DRUGTopical 2% Tofacitinib
Following participant selection, confirmation of eligibility criteria, and completion of the baseline clinical assessment (Day 0), each participant will receive one bottle of nail lacquer containing Tofacitinib 2% for home use throughout the study period. Application of the investigational product will be the responsibility of the participant and must be performed once daily, in accordance with the instructions provided by the research team. Prior to each new application, the participant must completely remove the previous layer of nail lacquer, ensuring that the nail surface is clean and dry. After removal, a new uniform layer of the product should be applied to the affected nail(s). The product must be used daily and continuously for the entire duration of the study, in compliance with the schedule established in the study protocol.
Sponsors
Hexsel Dermatology Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years; * Presence of nail psoriasis in at least one fingernail or toenail; * Patients not using systemic medication, or without adequate response to systemic medication after at least 6 months of use; * Ability to read, understand, and sign the Informed Consent Form (ICF) and the Consent Form for Images, Presentations, and Scientific Publications.
Exclusion criteria
Pregnant or breastfeeding women or those planning to become pregnant during the study period; * History of sensitivity to any components of the study product; * Initiation of systemic medication for nail psoriasis less than six months prior.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of topical 2% tofacitinib | 26 weeks | The Nail Psoriasis Severity Index (NAPSI) evaluates nail psoriasis severity by assessing a target nail for nail matrix and nail bed involvement. The nail is divided into four quadrants. Nail matrix psoriasis includes pitting, leukonychia, red spots in the lunula, and nail plate crumbling, while nail bed psoriasis comprises onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and nail bed hyperkeratosis. Each component is scored from 0 to 4 according to the number of quadrants affected (1 = 1/4, 2 = 2/4, 3 = 3/4, 4 = 4/4). The total NAPSI score per nail is calculated as the sum of matrix and nail bed scores, ranging from 0 to 8. The score is directly proportional to disease severity, with higher scores indicating greater nail involvement and a score of zero representing absence of nail manifestations. In clinical studies, a decrease in NAPSI score over time indicates clinical improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety, Quality of Life, and Treatment Adherence with 2% Tofacitinib | 26 weeks | The Dermatology Life Quality Index (DLQI) is a validated, standardized instrument used to assess the impact of dermatological diseases on patients' quality of life over the preceding seven days. The questionnaire consists of 10 items covering symptoms and feelings, daily activities, leisure, work or school, personal relationships, and treatment-related burden. Each item is scored on a four-point scale from 0 to 3, where 0 indicates "not at all" and 3 indicates "very much." The total DLQI score is calculated as the sum of all items, yielding a minimum score of 0 and a maximum score of 30. Interpretation is directly proportional to disease impact: higher scores reflect greater impairment and worse dermatology-related quality of life, whereas lower scores indicate less impact, with a score of zero representing no effect on quality of life. |
Outcome results
None listed