Trial · NCT01245140
Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis
NCT01245140, Phase 2, Completed, Stiefel, a GSK Company; results first posted 2017-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis. Trials, record NCT01245140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01245140
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis
- NCT number
- NCT01245140
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Psoriasis
- Interventions
- alitretinoin, Placebo
- First posted
- 2010-11-22
- Last updated
- 2017-12-21
- Other registries' IDs
- eudract:2010-022843-39
- Results first posted
- 2017-04-04
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment | Baseline and EOT (Week 24) or the last assessment | The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. |
| Primary | Number of Participants With PPPASI 50 Response and PPPASI 75 Response | From Baseline until EOT (Week 24) or the last assessment | The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline. |
| Secondary | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the EOT visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. |
| Secondary | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the End of Treatment visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value. |
| Secondary | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on the redness, thickness, and scaliness scores of plaques (0-4 each) for the head, upper extremities, trunk, and lower extremities and the area of psoriatic involvement score (0-6). The lowest possible mPASI score was zero and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. |
| Secondary | Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment | Baseline and EOT (Week 24) or the last assessment | Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on redness, thickness, and scaliness scores of plaques (0-4 each) for head, upper extremities, trunk, lower extremities and area of psoriatic involvement score (0-6). Lowest possible mPASI score was 0 and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. Change from Baseline is defined as the value at EOT minus baseline value. |
| Secondary | Number of Participants With mPASI 50 Response and mPASI 75 Response | From Baseline until EOT (Week 24) | Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). The fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated. mPASI 50 response and mPASI 75 response is defined as a 50% and 75% decrease, respectively, in the mPASI score from Baseline. |
| Secondary | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | Baseline, Week 12, and EOT (Week 24) | The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). |
| Secondary | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | Baseline, Week 12, and EOT (Week 24) | The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value. |
| Secondary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | From Baseline until safety follow up (Week 29) | An AE was any adverse change from the participant's Baseline (pre-treatment) clinical condition, including intercurrent illness, which occurred during the course of a clinical study after written informed consent had been given, whether considered related to treatment or not. The relationship of AEs to the study treatment was assessed as unrelated, remotely related, possibly related, and probably related. For an AE to be considered serious, it fell into one or more of the following categories: results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, and is a congenital abnormality or birth defect. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment | Baseline and EOT (Week 24) or the last assessment | Full Analysis Set : treated participants with \>=1 efficacy result after receiving study medication. | Scores on a scale | MEAN |
| PRIMARY | Number of Participants With PPPASI 50 Response and PPPASI 75 Response | From Baseline until EOT (Week 24) or the last assessment | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X). | Pustule count | MEAN |
| SECONDARY | Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X). | Pustule count | MEAN |
| SECONDARY | Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24) | Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X). | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment | Baseline and EOT (Week 24) or the last assessment | Full Analysis Set | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With mPASI 50 Response and mPASI 75 Response | From Baseline until EOT (Week 24) | Full analysis set. Participants with lesions in areas of the body other than the hands and feet were assessed. | Participants | NUMBER |
| SECONDARY | Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24) | Baseline, Week 12, and EOT (Week 24) | Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X). | Scores on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24) | Baseline, Week 12, and EOT (Week 24) | Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X). | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment | From Baseline until safety follow up (Week 29) | Safety Population: all randomized participants who received at least one dose of study medication | Participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group314
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment | Matching Placebo | -44.6 | Standard Deviation 45.9 | Scores on a scale | |
| Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment | Alitretinoin 30 mg | -45.2 | Standard Deviation 32.8 | Scores on a scale | |
| Number of Participants With PPPASI 50 Response and PPPASI 75 Response | Matching Placebo | PPPASI 50 response | 6 | Participants | |
| Number of Participants With PPPASI 50 Response and PPPASI 75 Response | Alitretinoin 30 mg | PPPASI 50 response | 11 | Participants | |
| Number of Participants With PPPASI 50 Response and PPPASI 75 Response | Matching Placebo | PPPASI 75 response | 3 | Participants | |
| Number of Participants With PPPASI 50 Response and PPPASI 75 Response | Alitretinoin 30 mg | PPPASI 75 response | 5 | Participants | |
| Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Matching Placebo | Baseline, n=9, 22 | 82.7 | Standard Deviation 59.1 | Pustule count |
| Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Alitretinoin 30 mg | Baseline, n=9, 22 | 106.0 | Standard Deviation 128.2 | Pustule count |
| Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Matching Placebo | Week 4, n=9, 20 | 71.6 | Standard Deviation 66.5 | Pustule count |
| Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24) | Alitretinoin 30 mg | Week 4, n=9, 20 | 31.0 | Standard Deviation 43.5 | Pustule count |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Matching Placebo | 9 | |
| Overall Study | STARTED | Alitretinoin 30 mg | 24 | |
| Overall Study | COMPLETED | Matching Placebo | 6 | |
| Overall Study | COMPLETED | Alitretinoin 30 mg | 14 | |
| Overall Study | NOT COMPLETED | Matching Placebo | 3 | |
| Overall Study | NOT COMPLETED | Alitretinoin 30 mg | 10 |
Source ClinicalTrials.gov
Adverse events62
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 | Nasopharyngitis | Infections and infestations | Matching Placebo | 1 | 9 | |
| other | Nasopharyngitis | Infections and infestations | Alitretinoin 30 mg | 7 | 24 | |
| other | Bronchitis | Infections and infestations | Matching Placebo | 1 | 9 | |
| other | Bronchitis | Infections and infestations | Alitretinoin 30 mg | 1 | 24 | |
| other | Headache | Nervous system disorders | Matching Placebo | 2 | 9 | |
| other | Headache | Nervous system disorders | Alitretinoin 30 mg | 8 | 24 | |
| other | Cheilitis | Gastrointestinal disorders | Matching Placebo | 1 | 9 | |
| other | Cheilitis | Gastrointestinal disorders | Alitretinoin 30 mg | 3 | 24 | |
| other | Nausea | Gastrointestinal disorders | Matching Placebo | 1 | 9 | |
| other | Nausea | Gastrointestinal disorders | Alitretinoin 30 mg | 2 | 24 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Matching Placebo | ||
| Total, all-cause mortality | Alitretinoin 30 mg | ||
| Total, other adverse events | Matching Placebo | 8 | 9 |
| Total, other adverse events | Alitretinoin 30 mg | 16 | 24 |
| Total, serious adverse events | Matching Placebo | 0 | 9 |
| Total, serious adverse events | Alitretinoin 30 mg | 1 | 24 |
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 |
|---|
| Alitretinoin 30 mg vs Matching 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.
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