Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails (NCT NCT00999687)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

31 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2019-08-07

Participant Flow

Participants recruited from ambulatory department of Chang Gung Memorial Hospital, in northern Taiwan between November 2009 and May 2011.

35 participants recruited and screened, 4 excluded (3 did not meet the eligibility criteria and 1 refused participation).

Participant milestones

Participant milestones
Measure	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.
First Intervention STARTED	31
First Intervention COMPLETED	30
First Intervention NOT COMPLETED	1
Second Intervention STARTED	30
Second Intervention COMPLETED	27
Second Intervention NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
First Intervention Withdrawal by Subject	1
Second Intervention Withdrawal by Subject	2
Second Intervention Lack of Efficacy	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants (Indigo Naturalis Oil Extract /Olive Oil) n=31 Participants 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.
Age, Continuous	40.7 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.

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.

Outcome measures

Outcome measures
Measure	Experimental Group n=30 Participants Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.	Control Group n=30 Participants Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
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. Change from Baseline in Single-Hand NAPSI	-10.9 units on a scale 95% Confidence Interval 6.0 • Interval -13.3 to -8.52	-4.9 units on a scale Interval -6.95 to -2.78
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. Change from Baseline in Modified-Target NAPSI	-8.1 units on a scale Interval -9.97 to -6.23	-2.2 units on a scale Interval -3.76 to -0.57

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.

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.

Outcome measures

Outcome measures
Measure	Experimental Group n=27 Participants Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.	Control Group n=27 Participants Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
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. Change from Baseline in Single-Hand NAPSI	-13.4 units on a scale Interval -16.4 to -10.5	-11.6 units on a scale Interval -14.2 to -9.05
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. Change from Baseline in Modified-Target NAPSI	-10.6 units on a scale Interval -12.6 to -8.54	-8.0 units on a scale Interval -9.74 to -6.34

Adverse Events

All Participants (Indigo Naturalis Oil Extreact/Olive Oil)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lin Yin-Ku MD.Ph.D.

Chang Gung Memorial Hospital

Phone: 886-2-24313131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place