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Palmoplantar KeratodermaPhase 2NCT06561321

Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma

A Phase 2 study testing Tapinarof in people with Palmoplantar Keratoderma, run by Indiana University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess adults with palmoplantar keratoderma (thickening skin layer on palms and soles) who are treated with the study drug, tapinarof. This is a naturally occuring compound used for the treatment of psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palmoplantar Keratoderma
What is being tested?
Tapinarof
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
30 Oct 2024to 31 Dec 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

  • Ability to discern and provide written informed consent and voluntarily adhere to all of the protocol requirements
  • Male or female subjects in their adult years (≥ 18 years of age), inclusive, from the time of providing written subject-investigator agreement.
  • Confirmed clinical diagnosis of palmoplantar keratoderma.

Who cannot join

  • Treatment with any of the following medications and therapies during the duration of the study*:
  • Topical corticosteroids
  • Keratolytic agents (eg, 6% salicylic acid, 70% propylene glycol, 30% water)
  • Topical retinoids
  • Topical vitamin D ointment (calcipotriol)
  • Oral retinoids (acitretin)
Show all 12Show fewer
  • If on any of these then a washout period of at least 2 weeks will be enforced before the study begins. This washout period is meant to ensure that any effects or residues from previous treatments are minimized before starting the study.
  • Prior exposure to Tapinarof treatment
  • Known history or suspicion of hypersensitivity reactions, or contraindications to any or all components of the drug or drugs of similar properties.
  • Currently participating in another clinical study for the same purpose.
  • Potential or confirmed pregnancy: Individuals who are currently pregnant or have confirmed pregnancy at the time of screening will be excluded from participation in the study. This criterion aims to ensure the safety of participants and adhere to ethical considerations regarding the potential risks associated with the study interventions during pregnancy.
  • Any other factors specifically not listed above but deemed patient unsuitable by the discretion of the investigators.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Department of Dermatology

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: An Open-label, Phase II Study to Evaluate the Clinical Efficacy and Safety of Tapinarof for Adult Patients With Palmoplantar Keratoderma

The purpose of this study is to assess adults with palmoplantar keratoderma (thickening skin layer on palms and soles) who are treated with the study drug, tapinarof. This is a naturally occuring compound used for the treatment of psoriasis. This study is being done to find out how well and safe this drug is for stopping or treating keratoderma. This study aims to investigate the positive impacts of daily topical Tapinarof use in the improvement of Keratoderma. Clinical efficacy and safety profile of prescribing Tapinarof for this condition will be evaluated.

Read the detailed description

This study aims to assess the benefits of the treatment. Should the treatment demonstrate benefits (as defined by the primary outcome measure) without any observed serious adverse events (SAEs), further clinical trials would be justified. If at least 2 out of 6 subjects benefits from the treatment (as defined by our primary outcome measure) and there are no SAEs, future clinical trials would be warranted. This initial data will determine whether it is worthwhile to proceed with a phase 2 trial, that will be both blinded and well-controlled.

The study is designed to gather preliminary experiences that can be used to design subsequent, well-controlled studies that are appropriately powered for statistical analysis. Currently, there is not enough experience with this medication in treating this specific condition, which is necessary to design successful randomized controlled trials (RCTs) for regulatory approval by the FDA. In dermatology, conducting studies in this manner is standard practice.

Being tested
Tapinarof
Keywords
Dermatology
Medical subject headings
Keratoderma, Palmoplantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TapinarofDrug

    Daily topical Tapinarof use will stop disease advancement and improve the quality of life in patients with palmoplantar keratoderma, through its AhR \& NRF2 agonism properties.

Study groups in NCT06561321
Study groupRoleWhat they receive
Tapinarof Drug TreatmentExperimentalSubjects in this arm will apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period. Participants who achieve disease clearance after 16 weeks may discontinue treatment and will be monitored for sustained response up to 52 weeks. Those who do not achieve clearance will continue the treatment during an extension period for up to 36 additional weeks or until clearance is achieved, whichever comes first. Regular follow-up visits will assess the duration of disease clearance and monitor for any potential recurrence of keratoderma.
Receives: Drug: Tapinarof

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physician's Global Assessment (PGA)

    To evaluate the treatment benefit of Tapinarof applied topically to patients affected with palmoplantar keratoderma.

    Either an overall change in the PGA score to 0 (clear) or 1 (almost clear) or a decrease from baseline of at least 2 points. Higher scores indicate a worse outcome.

    Title: PHYSICIAN GLOBAL ASSESSMENT Minimum value: 0 Maximum value: 5

    Measured: Week 16 (Visit 4)

Secondary outcomes (5)

  1. Treatment Emergent Adverse Event (TEAEs)

    To assess the safety of Tapinarof applied topically to patients affected with palmoplantar keratoderma.

    Frequency and severity of treatment emergent adverse events (TAEs).

    Measured: through study completion, 52 weeks

  2. Skin assessment every visit

    To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the investigator.

    Skin assessment of the affected areas, palms and/or soles, that are being managed with topical Tapinarof.

    Measured: through study completion, 52 weeks

  3. Skin pictures at baseline to 52 weeks

    To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the investigator.

    To identify and note any visible differences due to the application of Tapinarof, throughout the treatment phase from baseline, 4 weeks, end of primary endpoint and lastly at the end of the monitoring phase at 52 weeks.

    Measured: through study completion, 52 weeks

  4. Patient Global Assessment (PtGA)

    To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the patient.

    Note any patient reported outcomes and patient satisfaction of the treatment through a standardized Patient Global Assessment (PtGA) questionnaire. Higher scores indicate a worse outcome.

    Title: PATIENT GLOBAL ASSESSMENT Minimum value: 0 Maximum value: 5

    Measured: through study completion, 52 weeks

  5. Dermatology Life Quality Index (DLQI)

    To assess additional measures of efficacy of Tapinarof applied topically to patients affected with palmoplantar keratoderma, through qualitative analysis done by the patient. Done to monitor patient's observation and impact of Tapinarof use to their quality of life. Higher scores indicate a worse outcome.

    Title: DERMATOLOGY LIFE QUALITY INDEX Minimum value: 0 Maximum value: 30

    Measured: through study completion, 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start30 Oct 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Model description
The treatment duration will span 16 weeks. 1. Following this 16-week period, participants who achieve disease clearance may discontinue the treatment. Patients who stop treatment at 16 weeks will be assessed for their sustained drug response, and their status of clearance will be followed at regularly scheduled visits up to 52 weeks. 2. For those whose condition has not cleared, they will continue with the extension period with the treatment from 16 weeks until their disease becomes clear or until the conclusion of the study (52 weeks), whichever comes first. At the 52-week there will be a follow-up visit for all patients to monitor the response and check if they have maintained their response. As the drug already has a good safety profile and multiple assessments/outcome measures are being implemented, no additional follow-up is necessary but patients will be educated to come in for check-ups if any AEs persist.
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561321
Sponsor's protocol ID
21197
Status last verified
Jun 2026
First submitted
13 Aug 2024
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tapinarof in people with Palmoplantar Keratoderma, run by Indiana University at 1 site in United States.

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 3 inclusion and 12 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 23 Jun 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 United States. 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?

Physician's Global Assessment (PGA) (time frame: Week 16 (Visit 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561321.

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 23 Jun 2026.

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