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

NCT01445886 | Completed Phase 2 Results DMC

• 1 other identifier: CMRPG2A0191
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nail Psoriasis

Keywords

Nail Psoriasis; Indigo Naturalis; Indirubin; Calcipotriol; Nail Psoriasis Severity Index

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks

  The nails will be assessed by two dermatologists at baseline and after treatment 4, 8, 12, 16, 20, 24 weeks using single-handed Nail Psoriasis Severity Index (shNAPSI) score. shNAPSI evaluation: Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) , the total of which is the score for that nail (0-8); the range of shNAPSI of one hand is between 0 and 40, with higher score indicating more severe symptoms. Nail bed psoriasis: presence of any of the nail bed features (onycholysis, hemorrhages, hyperkeratosis, "oil drop" (salmon patch dyschroma): 0 for none, 1 for 1 quadrant only, 2 for 2 quadrants, 3 for 3 quadrants, and 4 for 4 quadrants. Nail matrix psoriasis: presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling): 0 for none, 1 if present in 1 quadrant of the nail, 2 if present in 2 quadrants of the nail, 3 if present in 3 quadrants of the nail, and 4 if present in 4 quadrants of the nail.

  Baseline and 24 weeks

Secondary Outcomes (2)

• Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail

  Baseline and 24 weeks

• Physician's and Subject's Global Assessment

  Week 24

Study Arms (2)

Indigo Naturalis Extract in Oil

EXPERIMENTAL

A 5-ml eye drop bottles contain indigo naturalis powder mixed with olive oil, and the concentration was 200 ug indirubin per ml. Each subject was asked to apply one to two drops (0.05 ml per drop) of the solution twice daily onto the nail folds, plus the hyponychium, of affected nails. The maximum period of treatment was 24 weeks or until there was complete clearing of their nail psoriasis.

Drug: Indigo Naturalis Extract in Oil

Calcipotriol solution

ACTIVE COMPARATOR

Calcipotriol solution (Daivonex® scalp solution, calcipotriol 50 ug/ml) was purchased from LEO Pharmaceutical Products, Ltd. (Ballerupt, Denmark) and also distributed into 5-ml eye drop bottles for this trial.Each subject was asked to apply one to two drops (0.05 ml per drop) of the solution twice daily onto the nail folds, plus the hyponychium, of affected nails. The maximum period of treatment was 24 weeks or until there was complete clearing of their nail psoriasis.

Drug: Calcipotriol Solution

Interventions

Indigo Naturalis Extract in Oil DRUG

The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.

Also known as: Lindioil

Indigo Naturalis Extract in Oil

Calcipotriol Solution DRUG

The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.

Also known as: Calcipotriol

Calcipotriol solution

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Concomitant topical treatment (corticosteroids), phototherapy, or any systemic treatment (retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) that could affect nail psoriasis.
• Patients with severe hepatic or renal disorders.
• Lactating, pregnant or planning pregnancy
• Unwillingness to comply with study protocol.
• A history of sensitivity to indigo naturalis. -

Sponsors & Collaborators

• Yin-ku Lin: lead
• Chang Gung University: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Related Publications (1)

• Lin YK, Chang YC, Hui RC, See LC, Chang CJ, Yang CH, Huang YH. A Chinese Herb, Indigo Naturalis, Extracted in Oil (Lindioil) Used Topically to Treat Psoriatic Nails: A Randomized Clinical Trial. JAMA Dermatol. 2015 Jun;151(6):672-4. doi: 10.1001/jamadermatol.2014.5460. No abstract available.

  PMID: 25738921 DERIVED

MeSH Terms

Interventions

Oils; calcipotriene

Intervention Hierarchy (Ancestors)

Lipids

Results Point of Contact

• Title: Yin-Ku Lin
• Organization: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung, Taiwan

lin1266@adm.cgmh.org.tw

886-2-2431-3131

Study Officials

• Yin-Ku Lin, M.D., Ph.D.

  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: SPONSOR INVESTIGATOR
• PI Title: Chief of Department of Traditional Chinese Medicine

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: October 4, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2013
• Last Updated: September 10, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

TW (1)