Phase 3
Completed N=33
Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis
Nail Psoriasis
Source: ClinicalTrials.gov NCT01445886 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks — 27.2; 27.4; 14.4; 20.4 units on a scale
◆ Published Evidence
Established
37citations · ~3 / year
A Chinese Herb, Indigo Naturalis, Extracted in Oil (Lindioil) Used Topically to Treat Psoriatic Nails: A Randomized Clinical Trial.
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.
Linked Publications
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A Chinese Herb, Indigo Naturalis, Extracted in Oil (Lindioil) Used Topically to Treat Psoriatic Nails: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks |
27.2; 27.4; 14.4; 20.4 | — |
| SECONDARY Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail |
17.7; 16.9; 5.9; 9.5 | — |
| SECONDARY Physician's and Subject's Global Assessment |
3.7; 2.5; 3.4; 2.3; 3.9; 2.6 | — |
Eligibility Criteria
Inclusion Criteria
- Nail psoriasis of the matrix and/or of the nail bed in at least one fingernail.
- Good general health.
- Agreement to avoid pregnancy for the study duration
Exclusion Criteria
- Concomitant topical treatment (corticosteroids), phototherapy, or any systemic treatment (retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) that could affect nail psoriasis.
- Patients with severe hepatic or renal disorders.
- Lactating, pregnant or planning pregnancy
- Unwillingness to comply with study protocol.
- A history of sensitivity to indigo naturalis. -
Data sourced from ClinicalTrials.gov (NCT01445886) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.