Trial · NCT00353119
A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
NCT00353119, Phase 3, Completed, Innovaderm Research Inc.; results first posted 2010-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis. Trials, record NCT00353119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00353119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
- NCT number
- NCT00353119
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- Innovaderm Research Inc.
- Conditions
- Palmoplantaris Pustulosis
- Interventions
- Placebo comparator, Etanercept
- First posted
- 2006-07-17
- Last updated
- 2011-09-09
- Results first posted
- 2010-12-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover | 12 weeks | Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 12 weeks in patients treated with placebo or etanercept PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). |
| Secondary | Number of Adverse Events | 28 weeks | Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment. |
| Secondary | Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) | 24 weeks | Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). |
| Secondary | Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover | 12 weeks | Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover | 12 weeks | The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary. | Percentage change | MEAN |
| SECONDARY | Number of Adverse Events | 28 weeks | Patients that crossed over from placebo to etanercept are included in the Etanercept group. The placebo group only included adverse events from the first 12 weeks prior to the crossover. The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary. | Adverse Events | NUMBER |
| SECONDARY | Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) | 24 weeks | The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary. | Percentage change | MEAN |
| SECONDARY | Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover | 12 weeks | The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary. | Percentage change | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover | Placebo | 30.1 | Standard Deviation 25.7 | Percentage change | |
| Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover | Etanercept | 7.1 | Standard Deviation 60.4 | Percentage change | |
| Number of Adverse Events | Placebo | 13 | Adverse Events | ||
| Number of Adverse Events | Etanercept | 57 | Adverse Events | ||
| Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) | Etanercept | 30.1 | Standard Deviation 36.1 | Percentage change | |
| Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover | Etanercept After Placebo | 52.1 | Standard Deviation 15.4 | Percentage change |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Day 0 to Week 12 | STARTED | Placebo Then Etanercept | 5 | |
| First Intervention Day 0 to Week 12 | STARTED | Etanercept | 10 | |
| First Intervention Day 0 to Week 12 | COMPLETED | Placebo Then Etanercept | 5 | |
| First Intervention Day 0 to Week 12 | COMPLETED | Etanercept | 10 | |
| First Intervention Day 0 to Week 12 | NOT COMPLETED | Placebo Then Etanercept | 0 | |
| First Intervention Day 0 to Week 12 | NOT COMPLETED | Etanercept | 0 | |
| Second Intervention Week 12 to Week 28 | STARTED | Placebo Then Etanercept | 5 | |
| Second Intervention Week 12 to Week 28 | STARTED | Etanercept | 10 | |
| Second Intervention Week 12 to Week 28 | COMPLETED | Placebo Then Etanercept | 5 | |
| Second Intervention Week 12 to Week 28 | COMPLETED | Etanercept | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 5 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Etanercept | 0 | 15 | 0 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo | 1 | 5 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Etanercept | 1 | 15 | 1 |
| other | Bilateral burning both feet | Nervous system disorders | Placebo | 0 | 5 | 0 |
| other | Bilateral burning both feet | Nervous system disorders | Etanercept | 1 | 15 | 1 |
| other | Bronchitis | Infections and infestations | Placebo | 1 | 5 | 1 |
| other | Bronchitis | Infections and infestations | Etanercept | 1 | 15 | 1 |
| other | Candida Vaginitis | Infections and infestations | Placebo | 0 | 5 | 0 |
| other | Candida Vaginitis | Infections and infestations | Etanercept | 1 | 15 | 1 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Etanercept | ||
| Total, other adverse events | Placebo | 5 | 5 |
| Total, other adverse events | Etanercept | 15 | 15 |
| Total, serious adverse events | Placebo | 0 | 5 |
| Total, serious adverse events | Etanercept | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Etanercept vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00353119
GET https://conductscience.org/api/trials/v1/NCT00353119/events?page=2