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NCT Number: NCT01445886

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

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.

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Key information

Conditions

Nail Psoriasis

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chang Gung Memorial Hospital

Keelung, 204, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Indigo Naturalis Extract in Oil

Drug

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: Lindioil

Calcipotriol Solution

Drug

The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.

Other names: Calcipotriol

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yin-ku Lin

Other

Collaborators

  • Chang Gung University

Registry information

Official study title

Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract and Calcipotriol Solution in Patients With Nail Psoriasis

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 4, 2011
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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