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Trial record 10 of 64 for:    Indigotindisulfonate sodium

Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis

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ClinicalTrials.gov Identifier: NCT01445886
Recruitment Status : Completed
First Posted : October 4, 2011
Results First Posted : August 28, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Chang Gung University
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 Nail Psoriasis
Interventions Drug: Indigo Naturalis Extract in Oil
Drug: Calcipotriol Solution
Enrollment 33
Recruitment Details Subjects with nail psoriasis were recruited from the outpatient Department of Traditional Chinese Medicine and Dermatology at the Chang Gung Memorial Hospital (CGMH), Taiwan from January 2011 to May 2012.
Pre-assignment Details This study screened 43 subjects with 33 recruited, and 28 subjects finished the study. ( 2 failure to return, 7 violation of selection criteria at entry, 3 other protocol violation and 3 refused treatment/withdraw violation)
Arm/Group Title Indigo Naturalis Extract in Oil VS Calcipotriol
Hide Arm/Group Description Patients were instructed to apply Lindioil (indigo naturalis extract in oil) to the fingernails of one hand (experimental group) and calcipotriol solution to the fingernails of the other hand (control group) twice daily for 24 weeks.
Period Title: Overall Study
Started 33
Completed 28
Not Completed 5
Reason Not Completed
Lost to Follow-up             2
Protocol Violation             3
Arm/Group Title Indigo Naturalis Extract in Oil VS Calcipotriol
Hide Arm/Group Description Patients were instructed to apply Lindioil (indigo naturalis extract in oil) to the fingernails of one hand (experimental group) and calcipotriol solution to the fingernails of the other hand (control group) twice daily for 24 weeks.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
41.9  (9.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
11
  33.3%
Male
22
  66.7%
1.Primary Outcome
Title Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks
Hide Description The nails will be assessed by two dermatologists at baseline and after treatment 4, 8, 12, 16, 20, 24 weeks using single-handed Nail Psoriasis Severity Index (shNAPSI) score. shNAPSI evaluation: Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) , the total of which is the score for that nail (0-8); the range of shNAPSI of one hand is between 0 and 40, with higher score indicating more severe symptoms. Nail bed psoriasis: presence of any of the nail bed features (onycholysis, hemorrhages, hyperkeratosis, “oil drop” (salmon patch dyschroma): 0 for none, 1 for 1 quadrant only, 2 for 2 quadrants, 3 for 3 quadrants, and 4 for 4 quadrants. Nail matrix psoriasis: presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling): 0 for none, 1 if present in 1 quadrant of the nail, 2 if present in 2 quadrants of the nail, 3 if present in 3 quadrants of the nail, and 4 if present in 4 quadrants of the nail.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indigo Naturalis Oil Extract Calcipotriol Solution
Hide Arm/Group Description:
Indigo Naturalis Oil Extract: The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 27.2  (7.83) 27.4  (8.55)
week 24 14.4  (8.85) 20.4  (8.47)
2.Secondary Outcome
Title Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail
Hide Description

The target nail will be assessed by two dermatologists before treatment and at week 4, 8, 12, 16, 20, 24 using modified target NAPSI score (mtNAPSI, 0-96).

mtNAPSI evaluation: a target nail is divided into 4 quadrants and for each quadrant the nail parameters (oil drop, onycholysis, hyperkeratosis, hemorrhages, pitting, leukonychia, red spots on the lunula, and crumbling) are assessed separately: 0 = no sign, 1 = mild, 2 = moderate, and 3 = severe; the range of mtNAPSI is between 0 and 96, with higher score indicating more severe symptoms.

Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indigo Naturalis Oil Extract Calcipotriol Solution
Hide Arm/Group Description:
Indigo Naturalis Oil Extract: The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Overall Number of Participants Analyzed 33 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 17.7  (6.17) 16.9  (6.45)
week 24 5.9  (4.11) 9.5  (5.16)
3.Secondary Outcome
Title Physician's and Subject's Global Assessment
Hide Description

The Physician's and Subject's Global Assessment (PGA and SGA) will be assessed by two dermatologists and participant himself/herself respectively after treatment 24 weeks.

A 6-point scale was used for both SGA and PGA: 0 = worse, 1 = 0–24% clearing with little or no change, 2 = 25–49% clearing with slight improvement, 3 = 50–74% clearing with moderate improvement, 4 = 75–99% clearing with striking improvement, 5 = cleared. A score between 3 and 5 was considered to be a positive response and a score between 0 and 2 a poor response.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indigo Naturalis Oil Extract Calcipotriol Solution
Hide Arm/Group Description:
Indigo Naturalis Oil Extract: The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
PGA 1 3.7  (0.82) 2.5  (1.26)
PGA 2 3.4  (1.10) 2.3  (1.36)
SGA 3.9  (0.76) 2.6  (1.23)
Time Frame Baseline and Week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indigo Naturalis Oil Extract Calcipotriol Solution
Hide Arm/Group Description Indigo Naturalis Oil Extract: The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks. Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
All-Cause Mortality
Indigo Naturalis Oil Extract Calcipotriol Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indigo Naturalis Oil Extract Calcipotriol Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Indigo Naturalis Oil Extract Calcipotriol Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
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
Organization: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung, Taiwan
Phone: 886-2-2431-3131 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: NCT01445886     History of Changes
Other Study ID Numbers: CMRPG2A0191
First Submitted: April 25, 2011
First Posted: October 4, 2011
Results First Submitted: June 18, 2014
Results First Posted: August 28, 2019
Last Update Posted: September 10, 2019