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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

Tracking Information
First Submitted Date  ICMJE November 25, 2009
First Posted Date  ICMJE December 1, 2009
Results First Submitted Date  ICMJE October 1, 2011
Results First Posted Date  ICMJE October 16, 2012
Last Update Posted Date October 16, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
  • Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. [ Time Frame: Baseline and 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 [ Time Frame: Baseline and Week 8 ]
    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. [ Time Frame: Baseline and Week 8 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
The changes in scaling, erythema, indurations and bilateral plaque areas are recorded from the beginning to the end of treatment. [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01022502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
  • Patients' Rating of the Overall Improvement at Week 8 [ Time Frame: Baseline and 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. [ Time Frame: Week 8 ]
    At the end of the trial, the patients were asked which ointment they preferred.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
Patient and Physician Global Assessment [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
Official Title  ICMJE Efficacy and Safety Comparison Between Refined and Crude Indigo Naturalis Ointment in the Treatment of Psoriatic Vulgaris
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: refined indigo naturalis ointment
    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.
    Other Name: refined ointment
  • Drug: crude indigo naturalis ointment
    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.
    Other Name: Crude ointment
Study Arms  ICMJE
  • Active Comparator: 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, starting on the date of enrollment in the study
    Intervention: Drug: refined indigo naturalis ointment
  • Active Comparator: crude indigo naturalis ointment
    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: Drug: crude indigo naturalis ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2009)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022502
Other Study ID Numbers  ICMJE CMRPG280391
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yin-ku Lin, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Yin-ku Lin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yin-Ku Lin, MD. PhD. Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP