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

NCT ID: NCT01445886

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-03-31

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.

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 33 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.

Conditions

Nail Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Indigo Naturalis Extract in Oil

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.

Group Type: EXPERIMENTAL

Indigo Naturalis Extract in Oil

Intervention Type: DRUG

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

Calcipotriol solution

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.

Group Type: ACTIVE_COMPARATOR

Calcipotriol Solution

Intervention Type: DRUG

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

Interventions

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 24 weeks.

Intervention Type: DRUG

Calcipotriol Solution

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

Intervention Type: DRUG

Other Intervention Names

Lindioil; Calcipotriol

Eligibility 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. -

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung University

OTHER

Sponsor Role: collaborator

Yin-ku Lin

OTHER

Sponsor Role: lead

Responsible Party

Yin-ku Lin

Chief of Department of Traditional Chinese Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yin-Ku Lin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Keelung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 25738921 (View on PubMed)

Other Identifiers

CMRPG2A0191

Identifier Type: -

Identifier Source: org_study_id