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Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
refined indigo naturalis ointment
crude indigo naturalis ointment
Sponsored by
Yin-ku Lin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring psoriasis, indigo naturalis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
  • Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
  • Patients were in good general health.
  • Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.

Exclusion Criteria:

  • Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
  • Patients had a history of allergy to indigo naturalis.
  • Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
  • Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

refined indigo naturalis ointment

crude indigo naturalis ointment

Arm Description

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 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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
Patients Preferred Ointment Type.
At the end of the trial, the patients were asked which ointment they preferred.

Full Information

First Posted
November 25, 2009
Last Updated
September 14, 2012
Sponsor
Yin-ku Lin
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1. Study Identification

Unique Protocol Identification Number
NCT01022502
Brief Title
Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
Official Title
Efficacy and Safety Comparison Between Refined and Crude Indigo Naturalis Ointment in the Treatment of Psoriatic Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yin-ku Lin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
psoriasis, indigo naturalis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
refined indigo naturalis ointment
Arm Type
Active Comparator
Arm Description
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
Arm Title
crude indigo naturalis ointment
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
refined indigo naturalis ointment
Other Intervention Name(s)
refined ointment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
crude indigo naturalis ointment
Other Intervention Name(s)
Crude ointment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
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
Title
Clearing Percentage of Target Plaque Area
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
Title
Percentage Improvement Compared to Baseline in the Target Plaque.
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
Secondary Outcome Measure Information:
Title
Patients' Rating of the Overall Improvement at Week 8
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
Title
Patients Preferred Ointment Type.
Description
At the end of the trial, the patients were asked which ointment they preferred.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study; Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years; Patients were in good general health. Female patients of childbearing age agreed to continue using birth control measures for the duration of the study. Exclusion Criteria: Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%; Patients had a history of allergy to indigo naturalis. Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment. Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Ku Lin, MD. PhD.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
204
Country
Taiwan

12. IPD Sharing Statement

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Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis

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