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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

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

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Detailed Description

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Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified.

Conditions

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Nail Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Indigo naturalis extract in oil

Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.

Group Type EXPERIMENTAL

Indigo Naturalis Extract in Oil

Intervention Type DRUG

Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks

Olive oil

Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.

Group Type PLACEBO_COMPARATOR

Indigo Naturalis Extract in Oil

Intervention Type DRUG

Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks

Olive Oil

Intervention Type OTHER

Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.

Interventions

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Indigo Naturalis Extract in Oil

Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks

Intervention Type DRUG

Olive Oil

Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.

Intervention Type OTHER

Other Intervention Names

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INEO

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes