Comparison · NCT00817063-2054aefb
Alitretinoin 30 mg vs Placebo: Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Alitretinoin 30 mg vs Placebo: Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment. Trial comparisons, record NCT00817063-2054aefb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00817063-2054aefb
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.393 | 0.339 | 0.449 | wilson | |
| Risk in group 2 | 0.138 | 0.103 | 0.181 | wilson | |
| Risk difference, group 1 minus group 2 | 0.255 | 0.186 | 0.321 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.85 | 2.08 | 3.92 | log | |
| Odds ratio, group 1 over group 2 | 4.05 | 2.71 | 6.07 | log | |
| Number needed to treat, for one more participant with the outcome on Alitretinoin 30 mg than on Placebo | 3.92 | 3.11 | 5.38 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Alitretinoin 30 mg | Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks. | 117 | 298 | OG000 |
| Group 2 | Placebo | Participants with severe CHE rated as refractory during the run-in period were randomized to receive matching Placebo oral soft capsule once daily up to 24 weeks. | 41 | 298 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment
- Description
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.
- Time frame
- Week 24 (end-of-treatment)
- Population
- ITT Population.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
- NCT number
- NCT00817063
- Phases
- PHASE3
- Conditions
- Eczema
- Interventions
- alitretinoin, Placebo
- Lead sponsor
- Stiefel, a GSK Company
- Results first posted
- 2017-11-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00817063?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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