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Trial record 10 of 62 for:    Indigotindisulfonate sodium

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

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ClinicalTrials.gov Identifier: NCT01445886
Recruitment Status : Completed
First Posted : October 4, 2011
Results First Posted : August 28, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Chang Gung University
Information provided by (Responsible Party):
Yin-ku Lin, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Drug: Indigo Naturalis Extract in Oil Drug: Calcipotriol Solution Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract and Calcipotriol Solution in Patients With Nail Psoriasis
Study Start Date : January 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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.
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 24 weeks.
Other Name: Lindioil

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.
Drug: Calcipotriol Solution
The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Other Name: Calcipotriol




Primary Outcome Measures :
  1. Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks [ Time Frame: 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 Outcome Measures :
  1. Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail [ Time Frame: 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.


  2. Physician's and Subject's Global Assessment [ Time Frame: 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.




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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445886


Locations
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Taiwan
Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Sponsors and Collaborators
Yin-ku Lin
Chang Gung University
Investigators
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Principal Investigator: Yin-Ku Lin, M.D., Ph.D. Chang Gung Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yin-ku Lin, Chief of Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01445886     History of Changes
Other Study ID Numbers: CMRPG2A0191
First Posted: October 4, 2011    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019
Keywords provided by Yin-ku Lin, Chang Gung Memorial Hospital:
Nail Psoriasis
Indigo Naturalis
Indirubin
Calcipotriol
Nail Psoriasis Severity Index
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Pharmaceutical Solutions
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents