MedTrace Logo

Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment

NCT01735864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-07-25

No results posted yet for this study

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

Interventions

DRUG

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

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

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

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

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yin-Ku Lin, MD., PhD. · Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01735864 on ClinicalTrials.gov