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

Nail Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999687
• Other study ID #: CMRPG280191
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

Intervention

Drug:
• 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

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.	Baseline and Week 12
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.	The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.	Baseline and Week 24