CompletedPhase 2/3

Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails

31 participantsStarted 2009-09

Plain-language summary

The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.

Who can participate

Age range20 Years – 65 Years

SexALL

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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.

What they're measuring

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.

Timeframe: Baseline and Week 12

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.

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT00999687

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

Results submitted2012-06-06

View on ClinicalTrials.gov More Nail Psoriasis trials