Phase 3
N=31
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
Nail Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00999687 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12. — -10.9; -4.9; -8.1; -2.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Indigo Naturalis Extract in Oil (Drug); Olive Oil (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12. |
-10.9; -4.9; -8.1; -2.2 | — |
| PRIMARY Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24. |
-13.4; -11.6; -10.6; -8.0 | — |
Summary
The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.
Eligibility Criteria
Inclusion criteria
- adults aged between 20 and 65 years
- received a diagnosis of nail psoriasis with at least one year history based on clinical assessment by two dermatologists and failure of topical systemic Chinese herbal anti-psoriasis therapy for fingernail psoriasis.
- Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.
Exclusion criteria
- Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis, total body surface involvement of more than 60%
- a history of allergy to indigo naturalis, or with onychomycosis or any fingernail infection.
- Patients have received systemic therapy within four weeks before enrollment
- Patients have received phototherapy within three weeks, or topical psoriasis agents within two weeks.
- Using medications which affect psoriasis during the study and unwillingness to comply with study protocol.
Data sourced from ClinicalTrials.gov (NCT00999687). 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.