Trial Outcomes & Findings for Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis (NCT NCT01445886)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

33 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2019-09-10

Participant Flow

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.

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)

Participant milestones

Participant milestones
Measure	Indigo Naturalis Extract in Oil VS Calcipotriol 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 Study STARTED	33
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Indigo Naturalis Extract in Oil VS Calcipotriol 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 Study Lost to Follow-up	2
Overall Study Protocol Violation	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indigo Naturalis Extract in Oil VS Calcipotriol n=33 Participants 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.
Age, Continuous	41.9 years STANDARD_DEVIATION 9.40 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

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.

Outcome measures

Outcome measures
Measure	Indigo Naturalis Oil Extract n=33 Participants 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 n=33 Participants Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks baseline	27.2 units on a scale Standard Deviation 7.83	27.4 units on a scale Standard Deviation 8.55
Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks week 24	14.4 units on a scale Standard Deviation 8.85	20.4 units on a scale Standard Deviation 8.47

SECONDARY outcome

Timeframe: Baseline and 24 weeks

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.

Outcome measures

Outcome measures
Measure	Indigo Naturalis Oil Extract n=33 Participants 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 n=33 Participants Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail baseline	17.7 units on a scale Standard Deviation 6.17	16.9 units on a scale Standard Deviation 6.45
Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail week 24	5.9 units on a scale Standard Deviation 4.11	9.5 units on a scale Standard Deviation 5.16

SECONDARY outcome

Timeframe: Week 24

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.

Outcome measures

Outcome measures
Measure	Indigo Naturalis Oil Extract n=28 Participants 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 n=28 Participants Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Physician's and Subject's Global Assessment PGA 1	3.7 units on a scale Standard Deviation 0.82	2.5 units on a scale Standard Deviation 1.26
Physician's and Subject's Global Assessment PGA 2	3.4 units on a scale Standard Deviation 1.10	2.3 units on a scale Standard Deviation 1.36
Physician's and Subject's Global Assessment SGA	3.9 units on a scale Standard Deviation 0.76	2.6 units on a scale Standard Deviation 1.23

Adverse Events

Indigo Naturalis Oil Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calcipotriol Solution

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

Yin-Ku Lin

Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung, Taiwan

Phone: 886-2-2431-3131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place