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

Yin-ku Lin

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nail Psoriasis

Treatments: Drug: Indigo Naturalis Extract in Oil; Drug: Calcipotriol Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01445886

CMRPG2A0191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Indigo Naturalis Extract in Oil

Experimental group

Description:

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.

Treatment:

Drug: Indigo Naturalis Extract in Oil

Calcipotriol solution

Active Comparator group

Description:

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.

Treatment:

Drug: Calcipotriol Solution