Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study

ConditionNail Psoriasis

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorHexsel Dermatology Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of sensitivity to any components of the study product;

Initiation of systemic medication for nail psoriasis less than six months prior.

Trial design

Design model

Single group

Treatments tested in this trial

Topical 2% Tofacitinib
Drug
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Medicated Nail LacquerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The efficacy of topical 2% tofacitinib

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.

Time frame

26 weeks

Secondary outcomes

Safety, Quality of Life, and Treatment Adherence with 2% Tofacitinib

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.

Time frame

26 weeks

Other outcomes

Monitoring of treatment adherence

This study evaluates the use of a medicated nail lacquer for the treatment of nail psoriasis, and one of the outcome measures will be the monitoring of treatment adherence, including the frequency of application and the correct execution of the nail lacquer application technique. Adherence will be systematically monitored throughout the study period using structured records to verify whether the product is applied in accordance with the dosing regimen and protocol-defined instructions. This monitoring aims to ensure intervention fidelity and to support the accurate interpretation of the treatment's efficacy and safety outcomes.

Time frame

26 weeks.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hexsel Dermatology Clinic

Lead sponsor

Source ClinicalTrials.gov

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