Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 20, 2009
January 3, 2013
September 2009
September 2010   (final data collection date for primary outcome measure)
  • 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.
Change from baseline in modified NAPSI for target fingernail over 24 weeks, and comparison of improvement of modified NAPSI of the indigo naturalis oil agent-treated and control fingernails. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00999687 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Nail Psoriasis
  • 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
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.
Interventions:
  • Drug: Indigo Naturalis Extract in Oil
  • Other: Olive Oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00999687
CMRPG280191
Yes
Yin-ku Lin, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Yin-Ku Lin, MD. PhD. Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP