Clinical trial NCT01445886: Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
Official title: Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract and Calcipotriol Solution in Patients With Nail Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nail Psoriasis
Keywords: Nail Psoriasis
Indigo Naturalis
Indirubin
Calcipotriol
Nail Psoriasis Severity Index
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung University
First posted: 2011-10-04
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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. -

Primary outcomes:
measure: Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail
timeFrame: Baseline and 24 weeks
measure: Physician's and Subject's Global Assessment
timeFrame: Week 24
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yin-Ku Lin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin YK, Chang YC, Hui RC, See LC, Chang CJ, Yang CH, Huang YH. A Chinese Herb, Indigo Naturalis, Extracted in Oil (Lindioil) Used Topically to Treat Psoriatic Nails: A Randomized Clinical Trial. JAMA Dermatol. 2015 Jun;151(6):672-4. doi: 10.1001/jamadermatol.2014.5460. No abstract available.