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Palmoplantar PustulosisProPuPNCT04459507

A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan

An observational study of Palmoplantar Pustulosis, run by Janssen Pharmaceutical K.K. at 39 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palmoplantar Pustulosis
How many people
276 participants
Where
39 sitesJapan
Study dates
22 Mar 2021to 27 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

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
  • Adult, Older adult

Study population: Participants observed in this study newly initiated/will be newly initiating a systemic therapy for their PPP/pustulotic arthro-osteitis (PAO) - either as their first systemic therapy or as a switch from, or an addition to a previous therapy, having had an inadequate response and/or intolerant to prior PPP/PAO therapy. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting.

Who may be able to join

  • Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) and/or pustulotic arthro-osteitis (PAO) in accordance with local clinical practice
  • Has previously been prescribed treatment for PPP/PAO
  • A decision has been made by the treating physician and the participant to commence treatment with a systemic PPP/PAO therapy, having been deemed to have an inadequate response to previous therapy (New users are defined as those participants to commence treatment on baseline visit date. Existing users are defined as those who commenced treatment prior to the baseline visit since 01 November 2019.)
  • Must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements

Who cannot join

  • Are receiving, or have received within the past 3 months, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, disease modifying antirheumatic drug (DMARDs), non-steroidal anti-inflammatory drugs, opioids, phosphodiesterase 4 (PDE4) inhibitor, or biologics for any other indication (for example, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and asthma)
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
  • Participation in an investigational study
  • Participation in another observational study for guselkumab (including a post marketing surveillance study)
  • If the only treatment they have received for PPP has been antibiotics

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Japan39 sites

  • Akita University Hospital

    Akita, 010-8543

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • Kyushu University Hospital

    Fukuoka, 812 8582

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

  • Kansai Medical University Hospital

    Hirakata, 573 1191

  • Hiroshima City Asa Citizens Hospital

    Hiroshima, 731-0293

  • Seiwakai Hiroshima Clinic

    Hiroshima, 733-0032

  • JR Sapporo Hospital

    Hokkaido, 060-0033

  • Kita-harima Medical Center

    Hyōgo, 6751392

  • Okayama Saiseikai General Hospital

    Kita-ku, 700-8511

  • Chikamori Hospital

    Kochi, 780-8522

  • Kochi Medical School Hospital

    Kochi, 783-8505

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • Kurashiki Medical Center

    Kurashiki-shi, 710-8522

  • Kurume University Hospital

    Kurume, 830-0011

  • Kuwana City Medical Center

    Kuwana, 511 0061

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Shinshu University Hospital

    Matsumoto, 390 8621

  • Toho University Medical Center, Ohashi Hospital

    Meguro-ku, 153-8515

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, 663-8501

  • Oita University Hospital

    Ōita, 879-5593

  • Okayama University Hospital

    Okayama, 700 8558

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Sasebo Chuo Hospital

    Sasebo, 857 1195

  • Tohoku University Hospital

    Sendai, 980 8574

  • Keio University Hospital

    Shinjuku-ku, 160-8582

  • Teikyo University Hospital

    tabashi City, 173 8606

  • Takamatsu Red Cross Hospital

    Takamatsu, 760 0017

  • St. Luke's International Hospital

    Tokyo, 104 8560

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998

  • Ehime University Hospital

    Tōon, 791-0295

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • Yokosuka Kyosai Hospital

    Yokosuka, 238 8558

Other trials in Japan

About this study

Official title: Registry of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan

The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.

Being tested
No intervention
Medical subject headings
Psoriasis

What participants receive

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

  • No interventionOther

    No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through participant charts and prospective data will be collected in accordance with clinical practice at the participant's clinic visits.

Study groups in NCT04459507
Study groupRoleWhat they receive
Participants With Palmoplantar pustulosis (PPP)Participants treated with a new systemic therapy for their PPP, having had an inadequate response to a prior PPP therapy either as their first systemic therapy or as a switch from, or addition to, a previous systemic therapy will be observed. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting. The primary data source for this study will be the medical records of each participant.
Receives: Other: No intervention

What is being measured

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

  1. Percentage of Participants who Remain on Their 'Index Systemic' Therapy

    Percentage of participants who remain on their 'index systemic' therapy will be reported.

    Measured: Up to 4.5 Years

  2. Percentage of Participants Ceasing Their 'Index Systemic' Therapy

    Percentage of participants ceasing their 'index systemic' therapy will be reported.

    Measured: Up to 4.5 Years

  3. Time to Cessation of Index Systemic Therapy From Baseline

    Time to cessation of index systemic therapy from baseline will be reported.

    Measured: Baseline, Up to 4.5 Years

Secondary outcomes (26)

  1. Percentage of Participants Receiving Each 'Index Systemic' Therapy

    Percentage of participants receiving each 'Index Systemic' therapy will be reported.

    Measured: Baseline

  2. Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy

    Percentage of participants adding a concurrent systemic treatment to their 'index systemic' therapy will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  3. Percentage of Participants Ceasing a Concurrent Systemic Treatment to their 'Index Systemic' Therapy

    Percentage of participants ceasing a concurrent systemic treatment to their 'index systemic' therapy will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  4. Time to Addition of a Concurrent Systemic Treatment to 'Index Systemic' Therapy

    Time to addition of a concurrent systemic treatment to 'index systemic' therapy will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  5. Time to Ceasing of a Concurrent Systemic Treatment to 'Index Systemic' Therapy

    Time to ceasing of a concurrent systemic treatment to 'index systemic' therapy will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  6. Percentage of Participants Changing the Dosage of their 'Index Systemic' Therapy

    Percentage of participants changing the dosage of their 'index systemic' therapy will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  7. Percentage of Participants Adding a Concurrent Non-Systemic Therapy to their 'Index Systemic' Therapy

    Percentage of participants adding a concurrent non-systemic therapy to their 'index systemic' therapy will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  8. Percentage of Participants Ceasing a Concurrent Non-Systemic Therapy to their 'Index Systemic' Therapy

    Percentage of participants ceasing a concurrent non-systemic therapy to their 'index systemic' therapy will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  9. Percentage of Participants Switching to a First Subsequent Systemic Therapy Within the Follow-up Period

    Percentage of participants switching to a first subsequent systemic therapy within the follow-up period will be reported.

    Measured: Every 6 Months Up to 4.5 Years

  10. Time to Commencement of First Subsequent Systemic Therapy From Baseline

    Time to commencement of first subsequent systemic therapy from baseline will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  11. Percentage of Participants Switching to a Second Subsequent Systemic Therapy Within the Follow-up Period

    Percentage of participants switching to a second subsequent systemic therapy within the follow-up period will be reported.

    Measured: Every 6 Months Up to 4.5 Years

  12. Time to Commencement of Second Subsequent Systemic Therapy From Baseline

    Time to commencement of second subsequent systemic therapy from baseline will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  13. Mean and Distribution of Dermatology Life Quality Index (DLQI) Scores at Baseline

    Mean and distribution of DLQI scores at baseline will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.

    Measured: Baseline

  14. Mean and Distribution of European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ-5D-5L) Scores at Baseline

    Mean and distribution of EQ-5D-5L scores at baseline will be reported. EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. A lower score indicates worse health.

    Measured: Baseline

  15. Mean and Distribution of Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline

    Mean and distribution of HAQ-DI scores at baseline will be reported. The Disability Index of the Health Assessment Questionnaire (HAQ-DI) assesses the functional status of the participant. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area where lower scores are indicative of better functioning.

    Measured: Baseline

  16. Mean and Distribution of Work Productivity and Activity Impairment: General Health (WPAI:GH) Scores at Baseline

    Mean and distribution of WPAI:GH scores at baseline will be reported. WPAI:GH questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. It consists of 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.

    Measured: Baseline

  17. Percentage of Participants with a Physician's Global Assessment (PGA) Score of 1 or Less (0 or 1)

    Percentage of participants with a PGA score of 1 or less (0 or 1) will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  18. Change From Baseline in PGA Score

    Change From baseline in PGA score will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  19. Change from Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Score

    The PPPASI assesses the severity of palmoplantar pustulosis lesions and their response to therapy. In the PPPASI system, the palms and soles are divided into 4 regions: the right palm, left palm, right sole, and left sole, which account for 20 percent (%), 20%, 30%, and 30%, respectively, of the total surface area of the palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicle and desquamation/scale, which are each rated on a scale of 0 to 4. The PPPASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  20. Change From Baseline in Pain Visual Analogue Scale (Pain-VAS) Score

    Change from baseline in Pain-VAS score will be reported. Pain-VAS is used to measure subjective pain status. It is a unilateral scale anchored at 0 (no pain) and 10 (worst pain imaginable).

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  21. Change in Primary Location of Pain

    Change in primary location of pain will be reported.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  22. Change From Baseline in DLQI Score

    Change from baseline in DLQI score will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  23. Change From Baseline in EQ5D-5L Index Score

    Change from baseline in EQ5D-5L index score will be reported. The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  24. Change from Baseline in HAQ-DI Index Score

    Change from baseline in HAQ-DI score will be reported. The HAQ-DI assesses the functional status of the participant. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area where lower scores are indicative of better functioning.

    Measured: Baseline and Every 6 Months Up to .4.5 Years

  25. Change from Baseline in Work Productivity and Activity Impairment questionnaire (WPAI)

    Change from baseline in WPAI will be reported. WPAI questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The higher the score the greater impact on productivity.

    Measured: Baseline and Every 6 Months Up to 4.5 Years

  26. Percentage of Participants with Adverse Events (AEs) and serious Adverse Events (SAEs)

    Percentage of participants with adverse events and serious Adverse Events will be reported. An adverse event is any untoward medical occurrence in a participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.

    Measured: Up to 4.5 Years

Timeline

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

  1. First posted7 Jul 2020
  2. Study start22 Mar 2021
  3. Primary completion27 Dec 2025
  4. Study completion27 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459507
Sponsor's protocol ID
CR108811
Other IDs
CNTO1959PAP4001
Acronym
ProPuP
Status last verified
Feb 2026
First submitted
2 Jul 2020
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

An observational study of Palmoplantar Pustulosis, run by Janssen Pharmaceutical K.K. at 39 sites in Japan.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Japan. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants who Remain on Their 'Index Systemic' Therapy (time frame: Up to 4.5 Years). The study lists 3 primary outcomes in all. 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 NCT04459507.

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 10 Feb 2026.

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