- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01445886
Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract and Calcipotriol Solution in Patients With Nail Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Keelung, Taiwan, 204
- Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nail psoriasis of the matrix and/or of the nail bed in at least one fingernail.
- Good general health.
- Agreement to avoid pregnancy for the study duration
Exclusion Criteria:
- Concomitant topical treatment (corticosteroids), phototherapy, or any systemic treatment (retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) that could affect nail psoriasis.
- Patients with severe hepatic or renal disorders.
- Lactating, pregnant or planning pregnancy
- Unwillingness to comply with study protocol.
- A history of sensitivity to indigo naturalis. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Indigo Naturalis Extract in Oil
A 5-ml eye drop bottles contain indigo naturalis powder mixed with olive oil, and the concentration was 200 ug indirubin per ml.
Each subject was asked to apply one to two drops (0.05 ml per drop) of the solution twice daily onto the nail folds, plus the hyponychium, of affected nails.
The maximum period of treatment was 24 weeks or until there was complete clearing of their nail psoriasis.
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The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Other Names:
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Active Comparator: Calcipotriol solution
Calcipotriol solution (Daivonex® scalp solution, calcipotriol 50 ug/ml) was purchased from LEO Pharmaceutical Products, Ltd. (Ballerupt, Denmark) and also distributed into 5-ml eye drop bottles for this trial.Each subject was asked to apply one to two drops (0.05 ml per drop) of the solution twice daily onto the nail folds, plus the hyponychium, of affected nails.
The maximum period of treatment was 24 weeks or until there was complete clearing of their nail psoriasis.
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The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks
Time Frame: Baseline and 24 weeks
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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.
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Baseline and 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail
Time Frame: Baseline and 24 weeks
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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. |
Baseline and 24 weeks
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Physician's and Subject's Global Assessment
Time Frame: Week 24
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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. |
Week 24
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yin-Ku Lin, M.D., Ph.D., Chang Gung Memorial Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Dermatologic Agents
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcipotriene
- Calcitriol
Other Study ID Numbers
- CMRPG2A0191
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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