Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Chang Gung University
Information provided by (Responsible Party):
Yin-ku Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01445886
First received: April 25, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to compare the efficacy and safety of indigo naturalis oil extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an effective alternative for those who do not respond well to traditional therapy.


Condition Intervention Phase
Nail Psoriasis
Drug: Indigo Naturalis Oil Extract
Drug: Calcipotriol Solution
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 and Calcipotriol Solution in Patients With Nail Psoriasis

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Change from Baseline in Nail Psoriasis Severity Index, NAPSI, at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    The nails will be assessed by two dermatologists before treatment and at week 4, 8, 12, 16, 20, 24 using NAPSI (Nail Psoriasis Severity Index) score.


Secondary Outcome Measures:
  • Change from Baseline in modified target NAPSI for the single most severely affected nail [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    The target nail will be assessed by two dermatologists before treatment and at week 4, 8, 12, 16, 20, 24 using modified NAPSI score.

  • Physician's and Patient's Global Assessment [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indigo Naturalis Oil Extract Drug: Indigo Naturalis Oil Extract
The participants applied indigo naturalis oil extract topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Active Comparator: Calcipotriol solution Drug: Calcipotriol Solution
The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.

Detailed Description:

In the literature, the efficacy of traditional Chinese medicine in treating nail psoriasis is rarely reported. Recently, the investigators developed a new product, indigo naturalis oil extract, which worked well in nail disease. In our randomized, observer-blind, vehicle-controlled trial showed that indigo naturalis oil extract is effective and safe in treating nail psoriasis. This study aims to compare the efficacy and safety of indigo naturalis oil extract with calcipotriol solution in patients with nail psoriasis using controlled, bilateral comparison

The investigators will enroll 32 patients with nail psoriasis from the ambulatory department of Chang Gung Memorial Hospital. Indigo naturalis oil extract will be consistently applied on either the left or right affected nail folds, while calcipotriol will be applied on the opposite side, both twice daily for 24 weeks, allowing intra-patient comparison. The nails will be assessed by two dermatologists before treatment and at week 2, 4, 8, 12, 16, 20, 24.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Nail psoriasis of the matrix and/or of the nail bed in at least one fingernail.
  2. Good general health.
  3. Agreement to avoid pregnancy for the study duration

Exclusion Criteria:

  1. Concomitant topical treatment (corticosteroids), phototherapy, or any systemic treatment (retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) that could affect nail psoriasis.
  2. Patients with severe hepatic or renal disorders.
  3. Lactating, pregnant or planning pregnancy
  4. Unwillingness to comply with study protocol.
  5. A history of sensitivity to indigo naturalis. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445886

Locations
Taiwan
Chang Gung Memorial Hospital
Keelung, Taiwan, 204
Sponsors and Collaborators
Yin-ku Lin
Chang Gung University
Investigators
Principal Investigator: Yin-Ku Lin, M.D., Ph.D. 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: NCT01445886     History of Changes
Other Study ID Numbers: CMRPG2A0191
Study First Received: April 25, 2011
Last Updated: March 10, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Nail Psoriasis
Indigo Naturalis
Indirubin
Calcipotriol
Nail Psoriasis Severity Index

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Calcitriol
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014