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

Last updated: July 24, 2019
Sponsor: Chang Gung Memorial Hospital
Overall Status: Completed

Phase

2/3

Condition

Psoriasis And Psoriatic Disorders

Rosacea

Rash

Treatment

N/A

Clinical Study ID

NCT00999687
CMRPG280191
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. adults aged between 20 and 65 years

  2. received a diagnosis of nail psoriasis with at least one year history based onclinical assessment by two dermatologists and failure of topical systemic Chineseherbal anti-psoriasis therapy for fingernail psoriasis.

  3. Female patients of childbearing age agreed to continue using birth control measuresfor the duration of the study.

Exclusion

Exclusion criteria:

  1. Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-inducedforms of psoriasis, total body surface involvement of more than 60%

  2. a history of allergy to indigo naturalis, or with onychomycosis or any fingernailinfection.

  3. Patients have received systemic therapy within four weeks before enrollment

  4. Patients have received phototherapy within three weeks, or topical psoriasis agentswithin two weeks.

  5. Using medications which affect psoriasis during the study and unwillingness to complywith study protocol.

Study Design

Total Participants: 31
Study Start date:
September 01, 2009
Estimated Completion Date:
September 30, 2010

Study 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.