Nail Psoriasis
Conditions
Keywords
Nail Psoriasis, Indigo Naturalis, Indirubin, Calcipotriol, Nail Psoriasis Severity Index
Brief summary
The purpose of this study is to compare the efficacy and safety of indigo naturalis oil extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an effective alternative for those who do not respond well to traditional therapy.
Detailed description
In the literature, the efficacy of traditional Chinese medicine in treating nail psoriasis is rarely reported. Recently, the investigators developed a new product, indigo naturalis oil extract, which worked well in nail disease. In our randomized, observer-blind, vehicle-controlled trial showed that indigo naturalis oil extract is effective and safe in treating nail psoriasis. This study aims to compare the efficacy and safety of indigo naturalis oil extract with calcipotriol solution in patients with nail psoriasis using controlled, bilateral comparison The investigators will enroll 33 patients with nail psoriasis from the ambulatory department of Chang Gung Memorial Hospital. Indigo naturalis oil extract will be consistently applied on either the left or right affected nail folds, while calcipotriol will be applied on the opposite side, both twice daily for 24 weeks, allowing intra-patient comparison. The nails will be assessed by two dermatologists before treatment and at week 2, 4, 8, 12, 16, 20, 24.
Interventions
The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
DRUGCalcipotriol Solution
The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Sponsors
Chang Gung University
Yin-ku Lin
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Nail psoriasis of the matrix and/or of the nail bed in at least one fingernail. 2. Good general health. 3. Agreement to avoid pregnancy for the study duration
Exclusion criteria
1. Concomitant topical treatment (corticosteroids), phototherapy, or any systemic treatment (retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) that could affect nail psoriasis. 2. Patients with severe hepatic or renal disorders. 3. Lactating, pregnant or planning pregnancy 4. Unwillingness to comply with study protocol. 5. A history of sensitivity to indigo naturalis. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail | 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. |
| Physician's and Subject's Global Assessment | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 3 |
Baseline characteristics
| Characteristic | Indigo Naturalis Extract in Oil VS Calcipotriol |
|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 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.
Time frame: Baseline and 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indigo Naturalis Oil Extract | 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 |
| Indigo Naturalis Oil Extract | 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 |
| Calcipotriol Solution | Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks | baseline | 27.4 units on a scale | Standard Deviation 8.55 |
| Calcipotriol Solution | Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks | week 24 | 20.4 units on a scale | Standard Deviation 8.47 |
Secondary
Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail
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.
Time frame: Baseline and 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indigo Naturalis Oil Extract | 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 |
| Indigo Naturalis Oil Extract | 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 |
| Calcipotriol Solution | Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail | baseline | 16.9 units on a scale | Standard Deviation 6.45 |
| Calcipotriol Solution | Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail | week 24 | 9.5 units on a scale | Standard Deviation 5.16 |
Secondary
Physician's and Subject's Global Assessment
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.
Time frame: Week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indigo Naturalis Oil Extract | Physician's and Subject's Global Assessment | SGA | 3.9 units on a scale | Standard Deviation 0.76 |
| Indigo Naturalis Oil Extract | Physician's and Subject's Global Assessment | PGA 1 | 3.7 units on a scale | Standard Deviation 0.82 |
| Indigo Naturalis Oil Extract | Physician's and Subject's Global Assessment | PGA 2 | 3.4 units on a scale | Standard Deviation 1.1 |
| Calcipotriol Solution | Physician's and Subject's Global Assessment | PGA 2 | 2.3 units on a scale | Standard Deviation 1.36 |
| Calcipotriol Solution | Physician's and Subject's Global Assessment | SGA | 2.6 units on a scale | Standard Deviation 1.23 |
| Calcipotriol Solution | Physician's and Subject's Global Assessment | PGA 1 | 2.5 units on a scale | Standard Deviation 1.26 |