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To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.
Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.
To improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| refined indigo naturalis ointment | Active Comparator | Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study |
|
| crude indigo naturalis ointment | Active Comparator | Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| refined indigo naturalis ointment | Drug | The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement. | Baseline and Week 8 |
| Clearing Percentage of Target Plaque Area | The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement. | Baseline and Week 8 |
| Percentage Improvement Compared to Baseline in the Target Plaque. | The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Rating of the Overall Improvement at Week 8 | At week 8, patients rated an overall response to treatment (separately for each side of the body), taking into account both the extent and the degree of the disease, compared with the pretreatment condition, on a 6-point scale (0=worse,1=poor, 2=fair, 3=good, 4=excellent, 5=cleared). A score of 4 or higher represents a better outcome. | Baseline and Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yin-Ku Lin, MD. PhD. | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Keelung | 204 | Taiwan |
41 participants recruited and screened,3 exclude ( 2 did not meet the eligibility criteria and 1 refuesed to participate).
Participants recruited from ambulatory department of Chang Gung Memorial Hospital,in northern Taiwan between November 2009 and May 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | In all participants, two bilateral symmetric plaques were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Participants were instructed to avoid cross-contamination between the two treatment sites by washing hands throughly between applications. Treatment was performed until complete clearing, up to a maxmum period of 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants (Refined/Crude Ointment) | Two symmetrically comparable plaques on each participant were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Photographs of the lesions were taken and lesion severity was evaluated at baseline and at week 2, 4, 6, and 8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement. | Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared PSI scores between the two lesions and before treatment with those after treatment. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Week 8 |
|
Week 2,4,6 and 8(end).
Adverse events were recorded at each visit and determined whether they were related to the study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crude Indigo Naturalis Ointment | Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment | Erythematous changes occurred at the beginning of treatment and resolved after a couple of days. Patch test results revealed no allergic responses, while monitoring tests for hematology, liver and renal function showed no significant findings. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yin-Ku Lin, MD. PhD. | Chang Gung Memorial Hospital | 886-2-24313131 | 2127 | lin1266@adm.cgmh.org.tw |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| crude indigo naturalis ointment | Drug | The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks. |
|
|
| Patients Preferred Ointment Type. | At the end of the trial, the patients were asked which ointment they preferred. | Week 8 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Refined Indigo Naturalis Ointment | Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks. |
|
|
| Primary | Clearing Percentage of Target Plaque Area | The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement. | Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared clearing percent of target plaque between the two lesions and before treatment with those after treatment. | Posted | Mean | 95% Confidence Interval | percentage of the target area | Baseline and Week 8 |
|
|
|
| Primary | Percentage Improvement Compared to Baseline in the Target Plaque. | The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement. | Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared percent of improvement related to baseline between the two lesions and before treatment with those after treatment. | Posted | Mean | 95% Confidence Interval | percent change of target plaque | Baseline and Week 8 |
|
|
|
| Secondary | Patients' Rating of the Overall Improvement at Week 8 | At week 8, patients rated an overall response to treatment (separately for each side of the body), taking into account both the extent and the degree of the disease, compared with the pretreatment condition, on a 6-point scale (0=worse,1=poor, 2=fair, 3=good, 4=excellent, 5=cleared). A score of 4 or higher represents a better outcome. | Total number of participants completing the 8 week period with study intervention and who reported excellent or cleared at week 8 were used for analysis. | Posted | Number | participants | Baseline and Week 8 |
|
|
|
| Secondary | Patients Preferred Ointment Type. | At the end of the trial, the patients were asked which ointment they preferred. | Total number of participants completing the 8 week period with study intervention. | Posted | Number | participants | Week 8 |
|
|
|
| 0 |
| 38 |
| 3 |
| 38 |
| EG001 | Refined Indigo Naturalis Ointment | Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax. | 0 | 38 | 1 | 38 |
|
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