Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment

NCT ID: NCT01735864

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-04-30

Brief Summary

The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat psoriasis has been proven effective in our previous study. This study aims to evaluate the efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of indirubin) in treatment of various local skin signs and thickness of psoriasis plaque.

Detailed Description

The use of indigo naturalis ointment to treat psoriasis has been proven effective in our previous clinical studies which demonstrated the efficacy and safety of topical indigo naturalis ointment, showing its ability to provide significant improvement of psoriatic skin lesions.

We developed a new formulation in which indigo naturalis powder is refined and reduces the blue discoloration of skin and clothes, making the treatment more user-friendly. We had observed an equivalent efficacy of the refined form of indigo naturalis (INEO) ointment on treating psoriasis as the crude form. However, it is necessary to determine an appropriate dosage of the refined form regarding its efficacy and safety.

This is a double-blind, 4-arm parallel study. The aim of this study is

1. To determine an appropriate dosage of indirubin in INEO ointment, regarding its efficacy and safety.

2. To evaluate the efficacy of INEO ointment in different local skin signs of plaque lesions.

3. To evaluate the efficacy of INEO in different traditional Chinese medicine clinical syndromes of psoriasis vulgaris.

4. To investigate the effects of INEO ointment on the immune system.

5. To evaluate the effects of INEO ointment in improving quality of life after treatment.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Indirubin 200 μg/g

per gram of ointment contains 200 μg of indirubin

Group Type: ACTIVE_COMPARATOR

Indirubin 200μg/g

Intervention Type: DRUG

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment containing 200 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Indirubin 100 μg/g

per gram of ointment contains 100 μg of indirubin

Group Type: ACTIVE_COMPARATOR

Indirubin 100 μg/g

Intervention Type: DRUG

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment contains 100 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Indirubin 50 μg/g

per gram of ointment contains 50 μg of indirubin

Group Type: ACTIVE_COMPARATOR

Indirubin 50 μg/g

Intervention Type: DRUG

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment contains 50 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Indirubin 10 μg/g

per gram of ointment contains 10 μg of indirubin

Group Type: ACTIVE_COMPARATOR

Indirubin 10 μg/g

Intervention Type: DRUG

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment contains 10 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Interventions

Indirubin 200μg/g

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment containing 200 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Intervention Type: DRUG

Indirubin 100 μg/g

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment contains 100 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Intervention Type: DRUG

Indirubin 50 μg/g

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment contains 50 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Intervention Type: DRUG

Indirubin 10 μg/g

1. Dosage form: Ointment

2. Dose(s): Each gram of ointment contains 10 μg of indirubin

3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily

Intervention Type: DRUG

Other Intervention Names

INEO ointment: Indirubin 200 μg/g; INEO ointment: Indirubin 100 μg/g; INEO ointment: Indirubin 50 μg/g; INEO ointment: Indirubin 10 μg/g

Eligibility Criteria

Inclusion Criteria

• Aged 20 - 65 years, men or women.
• Diagnosed as mild to moderate plaque-type psoriasis by the dermatologist, with psoriasis for a minimum of 1 year.
• Plaque psoriasis involving <20% of BSA and with PASI <20.
• Female patients of child-bearing age with negative pregnancy test at screening.
• Female patients of childbearing age who have agreed to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
• Willingness to comply with study protocol.
• With signed informed consent form.

Exclusion Criteria

• With history of topically or systematically hypersensitive to indigo naturalis or its excipient in ointment.
• With history of sensitivity to Chinese herb.
• Received systematic treatment for psoriasis within 4 weeks.
• Received topical treatment for psoriasis within 2 weeks.
• With abnormal liver or renal function, clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome,psychiatric disease, cancer or AIDS.
• Patients with pustular or erythrodermic psoriasis.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yin-ku Lin

MD., PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yin-Ku Lin, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung

Locations

Chang Gung Memorial Hospital at Keelung

Keelung, , Taiwan

Chang Gung Memorial Hospital at Taipei

Taipei, , Taiwan

Chang Gung Memorial Hospital at Linkou

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

NSC101-2325-B-182-018

Identifier Type: -

Identifier Source: org_study_id