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Trial record 2 of 62 for:    Indigotindisulfonate sodium

Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis

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ClinicalTrials.gov Identifier: NCT01022502
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
Yin-ku Lin, Chang Gung Memorial Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: refined indigo naturalis ointment
Drug: crude indigo naturalis ointment
Enrollment 38
Recruitment Details Participants recruited from ambulatory department of Chang Gung Memorial Hospital,in northern Taiwan between November 2009 and May 2010.
Pre-assignment Details 41 participants recruited and screened,3 exclude ( 2 did not meet the eligibility criteria and 1 refuesed to participate).
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 38 [1]
Completed 35 [2]
Not Completed 3
Reason Not Completed
Adverse Event             1
employment related reasons             1
Withdrawal by Subject             1
[1]
19 used the refined ointment on the right site, 19 used the crude ointment on the left site.
[2]
3 participants withdrew at week 4,5,6,respectively.
Arm/Group Title All Participants (Refined/Crude Ointment)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
42.8  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
7
  18.4%
Male
31
  81.6%
1.Primary Outcome
Title Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Hide Arm/Group Description:
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 was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
Overall Number of Participants Analyzed 35 35
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Scaling
-2.0
(-2.43 to -1.62)
-2.1
(-2.46 to -1.65)
Erythema
-1.7
(-2.14 to -1.35)
-2.0
(-2.35 to -1.59)
Induration
-1.9
(-2.29 to -1.60)
-2.0
(-2.34 to -1.60)
PSI score
-5.7
(-6.72 to -4.71)
-6.0
(-7.03 to -4.97)
2.Primary Outcome
Title Clearing Percentage of Target Plaque Area
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Hide Arm/Group Description:
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 was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
Overall Number of Participants Analyzed 35 35
Mean (95% Confidence Interval)
Unit of Measure: percentage of the target area
38.85
(24.48 to 53.22)
40.97
(22.54 to 59.40)
3.Primary Outcome
Title Percentage Improvement Compared to Baseline in the Target Plaque.
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Hide Arm/Group Description:
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 was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
Overall Number of Participants Analyzed 35 35
Mean (95% Confidence Interval)
Unit of Measure: percent change of target plaque
74.80
(62.57 to 87.04)
74.28
(59.40 to 89.16)
4.Secondary Outcome
Title Patients' Rating of the Overall Improvement at Week 8
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Hide Arm/Group Description:
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 was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: participants
21 23
5.Secondary Outcome
Title Patients Preferred Ointment Type.
Hide Description At the end of the trial, the patients were asked which ointment they preferred.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of participants completing the 8 week period with study intervention.
Arm/Group Title Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Hide Arm/Group Description:
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 was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: participants
1 31
Time Frame Week 2,4,6 and 8(end).
Adverse Event Reporting Description Adverse events were recorded at each visit and determined whether they were related to the study medication.
 
Arm/Group Title Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Hide Arm/Group Description Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax. Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.
All-Cause Mortality
Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Crude Indigo Naturalis Ointment Refined Indigo Naturalis Ointment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/38 (7.89%)      1/38 (2.63%)    
Skin and subcutaneous tissue disorders     
Erythema * 1 [1]  3/38 (7.89%)  3 1/38 (2.63%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
[1]
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yin-Ku Lin, MD. PhD.
Organization: Chang Gung Memorial Hospital
Phone: 886-2-24313131 ext 2127
EMail: lin1266@adm.cgmh.org.tw
Layout table for additonal information
Responsible Party: Yin-ku Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01022502     History of Changes
Other Study ID Numbers: CMRPG280391
First Submitted: November 25, 2009
First Posted: December 1, 2009
Results First Submitted: October 1, 2011
Results First Posted: October 16, 2012
Last Update Posted: October 16, 2012