Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment

NCT01735864 | Completed DMC

• 1 other identifier: NSC101-2325-B-182-018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis Vulgaris

Keywords

Indigo naturalis extract in oil

Outcome Measures

Primary Outcomes (1)

• Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups

  1. Mean change of total score (range 0-72) 2. Percentage change of PASI 3. Individual scores of scaling, erythema, and elevation by sites 4. Percentage of responder (\>50% of improvement, defined as clinical meaningful) and non-responder (less then 50% of improvement) 5. Percentage of subjects achieving "clear or almost clear" (defined as PASI \>90% of improvement)

  8 weeks

Secondary Outcomes (7)

• Body surface area (BSA)involved

  8 weeks

• Psoriasis Severity Index (PSI)

  8 weeks

• Efficacy in various local skin signs

  8 weeks

• Efficacy in different traditional Chinese medicine (TCM) clinical syndromes of psoriasis by PASI/PSI:

  8 weeks

• Physician's Global Assessment (PGA)

  8 weeks

Study Arms (4)

Indirubin 200 μg/g

ACTIVE COMPARATOR

per gram of ointment contains 200 μg of indirubin

Drug: Indirubin 200μg/g

Indirubin 100 μg/g

ACTIVE COMPARATOR

per gram of ointment contains 100 μg of indirubin

Drug: Indirubin 100 μg/g

Indirubin 50 μg/g

ACTIVE COMPARATOR

per gram of ointment contains 50 μg of indirubin

Drug: Indirubin 50 μg/g

Indirubin 10 μg/g

ACTIVE COMPARATOR

per gram of ointment contains 10 μg of indirubin

Drug: Indirubin 10 μg/g

Interventions

Indirubin 200μg/g 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

Also known as: INEO ointment: Indirubin 200 μg/g

Indirubin 200 μg/g

Indirubin 100 μg/g 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

Also known as: INEO ointment: Indirubin 100 μg/g

Indirubin 100 μg/g

Indirubin 50 μg/g 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

Also known as: INEO ointment: Indirubin 50 μg/g

Indirubin 50 μg/g

Indirubin 10 μg/g 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

Also known as: INEO ointment: Indirubin 10 μg/g

Indirubin 10 μg/g

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (3)

Chang Gung Memorial Hospital at Keelung

Keelung, Taiwan

Location

Chang Gung Memorial Hospital at Taipei

Taipei, 105, Taiwan

Location

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan

Location

MeSH Terms

Interventions

indirubin

Study Officials

• Yin-Ku Lin, MD., PhD.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., PhD.

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

TW (3)