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 nailPhysician'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
|