Overview

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

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Chang Gung Memorial Hospital
Criteria
Inclusion criteria:

1. adults aged between 20 and 65 years

2. 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.

3. Female patients of childbearing age agreed to continue using birth control measures
for the duration of the study.

Exclusion criteria:

1. Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced
forms of psoriasis, total body surface involvement of more than 60%

2. a history of allergy to indigo naturalis, or with onychomycosis or any fingernail
infection.

3. Patients have received systemic therapy within four weeks before enrollment

4. Patients have received phototherapy within three weeks, or topical psoriasis agents
within two weeks.

5. Using medications which affect psoriasis during the study and unwillingness to comply
with study protocol.