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Trial record 6 of 62 for:    Indigotindisulfonate sodium

Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails

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ClinicalTrials.gov Identifier: NCT00999687
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : September 12, 2012
Last Update Posted : August 7, 2019
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 Nail Psoriasis
Interventions Drug: Indigo Naturalis Extract in Oil
Other: Olive Oil
Enrollment 31
Recruitment Details Participants recruited from ambulatory department of Chang Gung Memorial Hospital, in northern Taiwan between November 2009 and May 2011.
Pre-assignment Details 35 participants recruited and screened, 4 excluded (3 did not meet the eligibility criteria and 1 refused participation).
Arm/Group Title All Participants (Indigo Naturalis Oil Extract /Olive Oil)
Hide Arm/Group Description In all participants, indigo naturalis oil extract (INOE) was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and INOE was applied to both hands twice daily for another 12 weeks.
Period Title: First Intervention
Started 31 [1]
Completed 30
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
16 used the INOE on the right hand,15 used the INOE on the left hand.
Period Title: Second Intervention
Started 30 [1]
Completed 27
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Lack of Efficacy             1
[1]
From week 13 to 24, all participants applied INOE to both hands twice daily.
Arm/Group Title All Participants (Indigo Naturalis Oil Extract /Olive Oil)
Hide Arm/Group Description In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
40.7  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
7
  22.6%
Male
24
  77.4%
1.Primary Outcome
Title Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.
Hide Description The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description:
Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
Overall Number of Participants Analyzed 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from Baseline in Single-Hand NAPSI
-10.9
(-13.30 to -8.52)
-4.9
(-6.95 to -2.78)
Change from Baseline in Modified-Target NAPSI
-8.1
(-9.97 to -6.23)
-2.2
(-3.76 to -0.57)
2.Primary Outcome
Title Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.
Hide Description The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.
Arm/Group Title Experimental Group Control Group
Hide Arm/Group Description:
Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
Using Olive Oil from week 0 to week 12, then transfer to Indigo Naturalis Oil Extract from week 13 to week 24
Overall Number of Participants Analyzed 27 27
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change from Baseline in Single-Hand NAPSI
-13.4
(-16.40 to -10.50)
-11.6
(-14.20 to -9.05)
Change from Baseline in Modified-Target NAPSI
-10.6
(-12.60 to -8.54)
-8.0
(-9.74 to -6.34)
Time Frame Baseline and Week 24
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants (Indigo Naturalis Oil Extreact/Olive Oil)
Hide Arm/Group Description

Experimental group: randomized to receive Indigo Naturalis Oil Extract first; Control group: randomized to receive Olive Oil first.

In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks.

All-Cause Mortality
All Participants (Indigo Naturalis Oil Extreact/Olive Oil)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants (Indigo Naturalis Oil Extreact/Olive Oil)
Affected / at Risk (%)
Total   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants (Indigo Naturalis Oil Extreact/Olive Oil)
Affected / at Risk (%)
Total   0/31 (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: Lin Yin-Ku MD.Ph.D.
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: NCT00999687     History of Changes
Other Study ID Numbers: CMRPG280191
First Submitted: October 20, 2009
First Posted: October 22, 2009
Results First Submitted: June 6, 2012
Results First Posted: September 12, 2012
Last Update Posted: August 7, 2019