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

NCT07313072 | Active Not Recruiting Phase 2

• 1 other identifier: 12-DPCHD25-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nail Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  26 weeks

Other Outcomes (1)

• Monitoring of treatment adherence

  26 weeks.

Study Arms (1)

Medicated Nail Lacquer

EXPERIMENTAL

Drug: Topical 2% Tofacitinib

Interventions

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.

Medicated Nail Lacquer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of sensitivity to any components of the study product;
• Initiation of systemic medication for nail psoriasis less than six months prior.

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (1)

Departamento de Pesquisa Clínicas Hexsel de Dermatologia

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Interventions

tofacitinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 31, 2025
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

BR (1)