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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yin-ku Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00999687
First received: October 20, 2009
Last updated: January 3, 2013
Last verified: January 2013
Results First Received: June 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Nail Psoriasis
Interventions: Drug: Indigo Naturalis Extract in Oil
Other: Olive Oil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited from ambulatory department of Chang Gung Memorial Hospital, in northern Taiwan between November 2009 and May 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
35 participants recruited and screened, 4 excluded (3 did not meet the eligibility criteria and 1 refused participation).

Reporting Groups
  Description
All Participants (Indigo Naturalis Oil Extract /Olive Oil) 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.

Participant Flow for 2 periods

Period 1:   First Intervention
    All Participants (Indigo Naturalis Oil Extract /Olive Oil)  
STARTED     31 [1]
COMPLETED     30  
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] 16 used the INOE on the right hand,15 used the INOE on the left hand.

Period 2:   Second Intervention
    All Participants (Indigo Naturalis Oil Extract /Olive Oil)  
STARTED     30 [1]
COMPLETED     27  
NOT COMPLETED     3  
Withdrawal by Subject                 2  
Lack of Efficacy                 1  
[1] From week 13 to 24, all participants applied INOE to both hands twice daily.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants (Indigo Naturalis Oil Extract /Olive Oil) 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.

Baseline Measures
    All Participants (Indigo Naturalis Oil Extract /Olive Oil)  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Mean ± Standard Deviation
  40.7  ± 12.6  
Gender  
[units: participants]
 
Female     7  
Male     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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.   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   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.   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lin Yin-Ku MD.Ph.D.
Organization: Chang Gung Memorial Hospital
phone: 886-2-24313131 ext 2127
e-mail: lin1266@adm.cgmh.org.tw


No publications provided


Responsible Party: Yin-ku Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00999687     History of Changes
Other Study ID Numbers: CMRPG280191
Study First Received: October 20, 2009
Results First Received: June 6, 2012
Last Updated: January 3, 2013
Health Authority: Taiwan: Institutional Review Board