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

Phase 2

Completed

Interventions: Drug: Indigo Naturalis Extract in Oil
Drug: Calcipotriol Solution

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.

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.

Recruitment & Eligibility

Inclusion Criteria

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. -

Arm && Interventions

Group	Intervention	Description
Indigo Naturalis Extract in Oil	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.
Calcipotriol solution	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks	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

Name	Time	Method
Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail	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.
Physician's and Subject's Global Assessment	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.