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Not yet recruiting NCT07313072

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

Phase II Interventional Nail Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Topical 2% Tofacitinib.
Who it may be relevant to
Registry conditions: Nail Psoriasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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 co

Primary outcome measures

  • The efficacy of topical 2% tofacitinib [Time frame: 26 weeks]
Secondary outcome measures (1)
  • Safety, Quality of Life, and Treatment Adherence with 2% Tofacitinib [Time frame: 26 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07313072 · 12-DPCHD25-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗