Trial · NCT00285779
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks | 12 weeks | Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale. |
| Secondary | Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks | Baseline; Week 24 | Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale. |
| Secondary | The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%. |
| Secondary | The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%. |
| Secondary | The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%. |
| Secondary | Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks | Week 12; Week 24 | This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse erythema. 0=clear, 1=mild/pink, 2=moderately red, 3=severely red/violaceous. |
| Secondary | Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks | Week 12; Week 24 | This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse elevation. 0=flat, 1=barely palpable (\<0.5 mm), 2=moderate (0.5 mm-1 mm), 3=severe (\>1 mm). |
| Secondary | Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks | Week 12; Week 24 | This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse scaling. 0=none, 1=fine/dusty scale, 2=moderate scale, 3=thick/tenacious scale. |
| Secondary | Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks | Week 12; Week 24 | This score sums all of the 3 elements of the target lesion score (erythema, elevation, scale) described in Outcome Measures 6-8. Assessment scores range from 0-9 on a Likert scale, with higher numbers meaning more severe disease in the target skin lesion. |
| Secondary | Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants were asked to indicate their pain level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less pain, higher scores correspond to more pain. |
| Secondary | Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants were asked to indicate their itching level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less itching, higher scores correspond to more itching. |
| Secondary | Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants were asked to indicate their rate their overall assessment of disease severity compared to where it was at their baseline visit. The scale ranges from 0-5, with lower scores correspond to more disease improvement. 0=clear/no disease, 1=much improved (\>75% improved), 2=improved (25-75%), 3=minimally improved (\<25%), 4=no change, 5=worsened disease. |
| Secondary | The Count of Subjects Experiencing Serious Adverse Events (SAEs) by Week 12 and Week 24 | Baseline; Week 12; Week 24 | A serious adverse event was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
| Secondary | The Count of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of "Clear") at 12 Weeks | 12 weeks | A complete response is defined as a score of 0 (representing "no disease") on the Physician Global Assessment. Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. This endpoint is the number of patients on placebo that had any score other than 0 on this measure. |
| Secondary | The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24 | 24 weeks |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00285779/registered