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

NCT00999687 | Completed Phase 2 Results DMC

• 1 other identifier: CMRPG280191
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nail Psoriasis

Keywords

Nail psoriasis; Indigo naturalis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Indigo naturalis extract in oil

EXPERIMENTAL

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.

Drug: Indigo Naturalis Extract in Oil

Olive oil

PLACEBO COMPARATOR

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.

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

Interventions

Indigo Naturalis Extract in Oil 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

Also known as: INEO

Indigo naturalis extract in oil; Olive oil

Olive Oil 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.

Olive oil

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Interventions

Oils; Olive Oil

Intervention Hierarchy (Ancestors)

Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Lin Yin-Ku MD.Ph.D.
• Organization: Chang Gung Memorial Hospital

lin1266@adm.cgmh.org.tw

886-2-24313131

Study Officials

• Yin-Ku Lin, MD. PhD.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of department of traditional Chinese medicine

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 22, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 7, 2019
• Results First Posted: September 12, 2012

Record last verified: 2019-07