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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nail Psoriasis
• Intervention / Treatment: Drug: Topical 2% Tofacitinib

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Medicated Nail Lacquer

Drug: Topical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	26 weeks.

Collaborators and Investigators

• Sponsor: Hexsel Dermatology Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: tofacitinib
• Other Study ID Numbers: 12-DPCHD25-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No