Phase 3 N=33 Randomized Single-blind Treatment

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

Nail Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT01445886 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Indigo Naturalis Extract in Oil (Drug); Calcipotriol Solution (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Yin-ku Lin
Primary completion: Jun 2012

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	—

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.

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. -

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01445886). 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.