Nail Psoriasis
Conditions
Keywords
Nail psoriasis, Indigo naturalis
Brief summary
The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.
Detailed description
Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified.
Interventions
Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks
OTHEROlive Oil
Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.
Sponsors
Chang Gung Memorial Hospital
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. adults aged between 20 and 65 years 2. received a diagnosis of nail psoriasis with at least one year history based on clinical assessment by two dermatologists and failure of topical systemic Chinese herbal anti-psoriasis therapy for fingernail psoriasis. 3. Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.
Exclusion criteria
1. Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis, total body surface involvement of more than 60% 2. a history of allergy to indigo naturalis, or with onychomycosis or any fingernail infection. 3. Patients have received systemic therapy within four weeks before enrollment 4. Patients have received phototherapy within three weeks, or topical psoriasis agents within two weeks. 5. Using medications which affect psoriasis during the study and unwillingness to comply with study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline and Week 12 | 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. |
| 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. | Baseline and Week 24 | 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. |
Participant flow
Recruitment details
Participants recruited from ambulatory department of Chang Gung Memorial Hospital, in northern Taiwan between November 2009 and May 2011.
Pre-assignment details
35 participants recruited and screened, 4 excluded (3 did not meet the eligibility criteria and 1 refused participation).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| First Intervention | Withdrawal by Subject | 1 |
| Second Intervention | Lack of Efficacy | 1 |
| Second Intervention | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Participants (Indigo Naturalis Oil Extract /Olive Oil) |
|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group | 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 |
| Experimental Group | 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 | — |
| Control Group | 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 | -4.9 units on a scale | — |
| Control Group | 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 | -2.2 units on a scale | — |
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.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental Group | 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 |
| Experimental Group | 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 |
| Control Group | 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 | -11.6 units on a scale |
| Control Group | 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 | -8.0 units on a scale |