Nail PsoriasisPhase 2NCT07313072
Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
A Phase 2 study testing Topical 2% Tofacitinib in people with Nail Psoriasis, run by Hexsel Dermatology Clinic at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Topical 2% Tofacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departamento de Pesquisa Clínicas Hexsel de Dermatologia
Porto Alegre, Rio Grande do Sul
About this 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.
- Conditions
- Nail Psoriasis
- Being tested
- Topical 2% Tofacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical 2% TofacitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Medicated Nail Lacquer | Experimental | Not described Receives: Drug: Topical 2% Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (1)
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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Sep 2026
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexsel Dermatology Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doris Hexsel, Hexsel Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313072
- Sponsor's protocol ID
- 12-DPCHD25-04
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT07313072
- Acronym / sponsor ID
- 12-DPCHD25-04
- Conditions
- Nail Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hexsel Dermatology ClinicUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medicated Nail Lacquer | Experimental | Drug: Topical 2% Tofacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical 2% TofacitinibFollowing 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. | Drug | Medicated Nail Lacquer |
Primary outcome
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.
1 secondary outcome
Safety, Quality of Life, and Treatment Adherence with 2% Tofacitinib
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical 2% Tofacitinib in people with Nail Psoriasis, run by Hexsel Dermatology Clinic at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of topical 2% tofacitinib (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.