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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nail Psoriasis

Treatments: Drug: Indigo Naturalis Extract in Oil; Other: Olive Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00999687

CMRPG280191

Details and patient eligibility

About

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

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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31 participants in 2 patient groups, including a placebo group

Indigo naturalis extract in oil

Experimental group

Description:

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.

Treatment:

Drug: Indigo Naturalis Extract in Oil

Olive oil

Placebo Comparator group

Description:

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.

Treatment:

Other: Olive Oil

Drug: Indigo Naturalis Extract in Oil