Trial · NCT00817063
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
NCT00817063, Phase 3, Completed, Stiefel, a GSK Company; results first posted 2017-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema. Trials, record NCT00817063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00817063
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
- NCT number
- NCT00817063
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 599 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Eczema
- Interventions
- alitretinoin, Placebo
- First posted
- 2009-01-06
- Last updated
- 2020-04-27
- Results first posted
- 2017-11-09
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Week 24 (end-of-treatment) | The investigator assigned PGA grades according to a 5-point scale (clear \[not detectable\], almost clear \[less than 10% of affected hand surface\], mild disease \[less than 10% of affected hand surface\], moderate disease \[10% to 30% of affected hand surface\], severe disease \[\>30% of affected hand surface\]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear. |
| Secondary | Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment | Baseline (Week 0) and Week 24 (end-of-treatment) | A 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) was used to grade 7 signs or symptoms of CHE. The mTLSS was calculated as sum of assigned scores for the symptoms of erythema, scaling, lichenification/hyperkeratosis, vesiculation, edema, fissures and Pruritus/Pain. The total score ranged from 0 (best) to 21 (worst). Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) \* 100. Data for Week 24 last observation carried forward (LOCF) has been presented. |
| Secondary | Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment | Week 24 (end-of-treatment) | At Week 24 or at the end-of-treatment participants were asked by the investigator to grade their overall change from Baseline by selecting one of the following descriptions, which best matched their perception of overall treatment effect: cleared or almost cleared (at least 90% clearing), marked improvement (at least 75% clearing), moderate improvement (at least 50% clearing), mild improvement (at least 25% clearing), no change and worsening. Participants were considered as responders when the PaGa was cleared or almost cleared. |
| Secondary | Percentage Change From Baseline in Extent of Disease at End-of-treatment | Baseline (Week 0) and Week 24 (end-of-treatment) | The extent of disease was estimated as the percentage of hand area (with 100% defined as the palmar and dorsal aspects) affected by eczema at Baseline, and at the end of treatment). Extent of disease was estimated separately for the left and right hands, and the overall extent of disease for both hands was calculated as (Left+Right)/2. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) \* 100. |
| Secondary | Response Duration for Responding Participants at the End-of-therapy | Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) | Response Duration was defined as time from the end-of-therapy to the first diagnosis of mild, moderate, or severe CHE. Median and inter-quartile range has been presented. |
| Secondary | Time to Relapse for Responding Participants at the End-of-therapy | Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) | Time to relapse was defined as the time from end-of-therapy to the first diagnosis of severe CHE. Median and inter-quartile range has been presented. The median was based on the very last participant having a follow-up period longer than expected, those explaining the high median. |
| Secondary | Time to Response for Responding Participants at End-of-therapy | Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) | Time to response was defined as time from start of treatment to first PGA assessment of "clear" or "almost clear". Median and inter-quartile range has been presented. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | Up to Week 24 (end-of-treatment) | An AE was defined as any adverse change from the participant's Baseline (pretreatment) clinical condition, including intercurrent illness, which occurred during the course of the clinical study after written informed consent had been given, whether considered related to treatment or not. A treatment-emergent AE was defined as any adverse change that occurred after treatment started and up to 7 days after last treatment. An SAE was any experience that suggested a significant hazard, contradiction, side effect or precaution. It was any adverse event that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. |
| Secondary | Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range | Up to Week 28 | Blood samples were collected for the assessment of laboratory parameters hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin concentration, reticulocytes, platelets, white blood cell, lymphocytes, neutrophils, monocytes, eosinophils, basophils, total bilirubin, bilirubin conjugated (direct), aspartate amino transferase (AST), alanine amino transferase (ALT), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), alkaline phosphatase (ALP), total protein, serum albumin, glucose, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, sodium, potassium, chloride, serum calcium, serum phosphate, serum creatinine, blood urea nitrogen (BUN)/urea, uric acid, Free thyroxin and thyroid stimulating hormone (TSH) at Baseline and every 4 weeks of treatment period and Week 28 of follow up period. Data for participants with values outside the marked reference range are reported. |
| Secondary | Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks | Up to Week 24 | The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., "your feelings being easily hurt") on a 5-point scale where, 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely (0 indicates best outcome and 4 indicates worst outcome). The total score ranged from 0 (best outcome) to 212 (worse outcome). Participants with an increase above Baseline of 25% or more on any domain subscore in BSI-53, or with an increase above Baseline of \>=2 points or a score \>=3 on any BSI-53 item that reflects depression, suicidality, psychotic symptoms, and hostility/aggression, were to be referred to a psychiatrist within 2 weeks. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Week 24 (end-of-treatment) | ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment | Baseline (Week 0) and Week 24 (end-of-treatment) | ITT population. | Percent change | MEAN |
| SECONDARY | Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment | Week 24 (end-of-treatment) | ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline in Extent of Disease at End-of-treatment | Baseline (Week 0) and Week 24 (end-of-treatment) | ITT Population. Only those participants available at the indicated time points were analyzed. | Percent change | MEAN |
| SECONDARY | Response Duration for Responding Participants at the End-of-therapy | Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) | ITT population. | Weeks | MEDIAN |
| SECONDARY | Time to Relapse for Responding Participants at the End-of-therapy | Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) | ITT population. | Weeks | MEDIAN |
| SECONDARY | Time to Response for Responding Participants at End-of-therapy | Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up) | ITT population. Only those participant who responded to PGA assessment at the end of therapy was analyzed. | Days | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | Up to Week 24 (end-of-treatment) | Safety Population included all randomized participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range | Up to Week 28 | Safety Population. Only those participants available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks | Up to Week 24 | Safety population. Only those participants meeting the criteria of referring to psychiatrist were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group340
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Alitretinoin 30 mg | Clear | 58 | Participants | |
| Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Placebo | Clear | 14 | Participants | |
| Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Alitretinoin 30 mg | Almost clear | 60 | Participants | |
| Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Placebo | Almost clear | 30 | Participants | |
| Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Alitretinoin 30 mg | Total | 118 | Participants | |
| Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 | Placebo | Total | 44 | Participants | |
| Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment | Alitretinoin 30 mg | -53.99 | Standard Deviation 40.160 | Percent change | |
| Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment | Placebo | -29.86 | Standard Deviation 37.830 | Percent change | |
| Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment | Alitretinoin 30 mg | 117 | Participants | ||
| Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment | Placebo | 41 | Participants |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alitretinoin 30 mg | 298 | |
| Overall Study | STARTED | Placebo | 298 | |
| Overall Study | COMPLETED | Alitretinoin 30 mg | 161 | |
| Overall Study | COMPLETED | Placebo | 128 | |
| Overall Study | NOT COMPLETED | Alitretinoin 30 mg | 137 | |
| Overall Study | NOT COMPLETED | Placebo | 170 |
Source ClinicalTrials.gov
Adverse events34
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 | Upper respiratory tract infection | Infections and infestations | Alitretinoin 30 mg | 20 | 296 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 13 | 298 | |
| other | Headache | Nervous system disorders | Alitretinoin 30 mg | 87 | 296 | |
| other | Headache | Nervous system disorders | Placebo | 24 | 298 | |
| other | Flushing | Vascular disorders | Alitretinoin 30 mg | 17 | 296 | |
| other | Flushing | Vascular disorders | Placebo | 1 | 298 | |
| other | Nausea | Gastrointestinal disorders | Alitretinoin 30 mg | 22 | 296 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 298 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Alitretinoin 30 mg | 0 | 296 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 1 | 298 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alitretinoin 30 mg | 1 | 296 |
| Total, all-cause mortality | Placebo | 2 | 298 |
| Total, other adverse events | Alitretinoin 30 mg | 108 | 296 |
| Total, other adverse events | Placebo | 36 | 298 |
| Total, serious adverse events | Alitretinoin 30 mg | 7 | 296 |
| Total, serious adverse events | Placebo | 3 | 298 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Alitretinoin 30 mg vs Placebo: Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment | Trial comparisons |
| Alitretinoin 30 mg vs Placebo: deaths from any cause | Trial comparisons |
| Alitretinoin 30 mg vs Placebo: serious adverse events | 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/NCT00817063
GET https://conductscience.org/api/trials/v1/NCT00817063/results?page=2