Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
|Nail Psoriasis||Drug: Indigo Naturalis Oil Extract Drug: Calcipotriol Solution||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract and Calcipotriol Solution in Patients With Nail Psoriasis|
- Change from Baseline in Nail Psoriasis Severity Index, NAPSI, at 24 weeks [ Time Frame: 24 weeks ]The nails will be assessed by two dermatologists before treatment and at week 4, 8, 12, 16, 20, 24 using NAPSI (Nail Psoriasis Severity Index) score.
- Change from Baseline in modified target NAPSI for the single most severely affected nail [ Time Frame: 24 weeks ]The target nail will be assessed by two dermatologists before treatment and at week 4, 8, 12, 16, 20, 24 using modified NAPSI score.
- Physician's and Patient's Global Assessment [ Time Frame: Week 24 ]
|Study Start Date:||January 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: Indigo Naturalis Oil Extract||
Drug: Indigo Naturalis Oil Extract
The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
|Active Comparator: Calcipotriol solution||
Drug: Calcipotriol Solution
The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445886
|Chang Gung Memorial Hospital|
|Keelung, Taiwan, 204|
|Principal Investigator:||Yin-Ku Lin, M.D., Ph.D.||Chang Gung Memorial Hospital|