Topical Use of 2% Tofacitinib for Nail… | Clinical Trial

Key information

Conditions

Nail Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

The efficacy of topical 2% tofacitinib

Time frame: 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 outcomes

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

Time frame: 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.

Other outcomes

Monitoring of treatment adherence

Time frame: 26 weeks.

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.

Sponsors and collaborators

Lead sponsor

Hexsel Dermatology Clinic

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 31, 2025
Registry last updated: Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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