Trial Outcomes & Findings for Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis (NCT NCT01022502)
NCT ID: NCT01022502
Last Updated: 2012-10-16
Results Overview
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.
COMPLETED
PHASE2
38 participants
Baseline and Week 8
2012-10-16
Participant Flow
Participants recruited from ambulatory department of Chang Gung Memorial Hospital,in northern Taiwan between November 2009 and May 2010.
41 participants recruited and screened,3 exclude ( 2 did not meet the eligibility criteria and 1 refuesed to participate).
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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38
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
employment related reasons
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1
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
Baseline characteristics by cohort
| Measure |
All Participants (Refined/Crude Ointment)
n=38 Participants
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.
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|---|---|
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Age Continuous
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42.8 years
STANDARD_DEVIATION 12.7 • n=93 Participants
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Sex: Female, Male
Female
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7 Participants
n=93 Participants
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Sex: Female, Male
Male
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31 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Crude Indigo Naturalis Ointment
n=35 Participants
Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
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Refined Indigo Naturalis Ointment
n=35 Participants
Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
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|---|---|---|
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Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
Scaling
|
-2.0 units on a scale
95% Confidence Interval 0.90 • Interval -2.43 to -1.62
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-2.1 units on a scale
95% Confidence Interval 0.87 • Interval -2.46 to -1.65
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Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
Erythema
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-1.7 units on a scale
95% Confidence Interval 0.85 • Interval -2.14 to -1.35
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-2.0 units on a scale
95% Confidence Interval 0.80 • Interval -2.35 to -1.59
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Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
Induration
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-1.9 units on a scale
95% Confidence Interval 0.82 • Interval -2.29 to -1.6
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-2.0 units on a scale
95% Confidence Interval 0.84 • Interval -2.34 to -1.6
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Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
PSI score
|
-5.7 units on a scale
95% Confidence Interval 2.34 • Interval -6.72 to -4.71
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-6.0 units on a scale
95% Confidence Interval 2.30 • Interval -7.03 to -4.97
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PRIMARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Crude Indigo Naturalis Ointment
n=35 Participants
Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
|
Refined Indigo Naturalis Ointment
n=35 Participants
Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
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|---|---|---|
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Clearing Percentage of Target Plaque Area
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38.85 percentage of the target area
Interval 24.48 to 53.22
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40.97 percentage of the target area
Interval 22.54 to 59.4
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PRIMARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Crude Indigo Naturalis Ointment
n=35 Participants
Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
|
Refined Indigo Naturalis Ointment
n=35 Participants
Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
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|---|---|---|
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Percentage Improvement Compared to Baseline in the Target Plaque.
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74.80 percent change of target plaque
Interval 62.57 to 87.04
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74.28 percent change of target plaque
Interval 59.4 to 89.16
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SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Crude Indigo Naturalis Ointment
n=35 Participants
Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
|
Refined Indigo Naturalis Ointment
n=35 Participants
Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
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|---|---|---|
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Patients' Rating of the Overall Improvement at Week 8
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21 participants
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23 participants
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SECONDARY outcome
Timeframe: Week 8Population: Total number of participants completing the 8 week period with study intervention.
At the end of the trial, the patients were asked which ointment they preferred.
Outcome measures
| Measure |
Crude Indigo Naturalis Ointment
n=35 Participants
Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
|
Refined Indigo Naturalis Ointment
n=35 Participants
Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
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|---|---|---|
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Patients Preferred Ointment Type.
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1 participants
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31 participants
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Adverse Events
Crude Indigo Naturalis Ointment
Refined Indigo Naturalis Ointment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crude Indigo Naturalis Ointment
n=38 participants at risk
Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax.
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Refined Indigo Naturalis Ointment
n=38 participants at risk
Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Erythema
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7.9%
3/38 • Number of events 3 • 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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2.6%
1/38 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place