Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
This study has been completed.
Sponsor:
Chang Gung Memorial Hospital
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
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Purpose
The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Nail Psoriasis |
Drug: Indigo Naturalis Extract in Oil Other: Olive Oil |
Phase 2 Phase 3 |
| 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 |
| Official Title: | Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails |
Resource links provided by NLM:
Further study details as provided by Chang Gung Memorial Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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. [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]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.
| Enrollment: | 31 |
| Study Start Date: | September 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Indigo naturalis extract in oil
In all participants, indigo naturalis extract in oil was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 24 weeks.
|
Drug: Indigo Naturalis Extract in Oil
The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 12 weeks.
Other Name: INEO
Other: Olive Oil
Patients were instructed to apply olive oil on one of two bilaterally symmetrical psoriatic finger nails which were different to the INOE side twice daily for first 12 weeks, after that, indigo naturalis oil extract was applied to replace olive oil for another 12 weeks.
Other Name: Control
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- adults aged between 20 and 65 years
- 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.
- Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.
Exclusion criteria:
- Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis, total body surface involvement of more than 60%
- a history of allergy to indigo naturalis, or with onychomycosis or any fingernail infection.
- Patients have received systemic therapy within four weeks before enrollment
- Patients have received phototherapy within three weeks, or topical psoriasis agents within two weeks.
- Using medications which affect psoriasis during the study and unwillingness to comply with study protocol.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Yin-ku Lin, Chief of department of traditional Chinese medicine, 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 |
Keywords provided by Chang Gung Memorial Hospital:
|
Nail psoriasis Indigo naturalis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013