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

Information source: Chang Gung Memorial Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nail Psoriasis

Intervention: Indigo Naturalis Oil Extract (Drug); Calcipotriol Solution (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Yin-ku Lin

Official(s) and/or principal investigator(s):
Yin-Ku Lin, M.D., Ph.D., Principal Investigator, Affiliation: Chang Gung Memorial Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from Baseline in Nail Psoriasis Severity Index, NAPSI, at 24 weeks

Secondary outcome:

Change from Baseline in modified target NAPSI for the single most severely affected nail

Physician's and Patient's Global Assessment

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 32 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.

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

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. -

Locations and Contacts

Chang Gung Memorial Hospital, Keelung 204, Taiwan
Additional Information

Starting date: January 2011
Last updated: March 10, 2014

Page last updated: August 20, 2015

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