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

History of Changes

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.

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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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.

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

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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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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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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

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