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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yin-ku Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00999687
First received: October 20, 2009
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Nail Psoriasis
Drug: Indigo Naturalis Extract in Oil
Other: Olive Oil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.

  • 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. [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indigo naturalis extract in oil
In all participants, indigo naturalis extract in oil was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 24 weeks.
Drug: Indigo Naturalis Extract in Oil
The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 12 weeks.
Other Name: INEO
Other: Olive Oil
Patients were instructed to apply olive oil on one of two bilaterally symmetrical psoriatic finger nails which were different to the INOE side twice daily for first 12 weeks, after that, indigo naturalis oil extract was applied to replace olive oil for another 12 weeks.
Other Name: Control

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999687

Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yin-Ku Lin, MD. PhD. Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Yin-ku Lin, Chief of department of traditional Chinese medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00999687     History of Changes
Other Study ID Numbers: CMRPG280191
Study First Received: October 20, 2009
Results First Received: June 6, 2012
Last Updated: January 3, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Nail psoriasis
Indigo naturalis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014