NCT01735864

Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment

Evaluation of the Efficacy and Safety of Indigo Naturalis Extract in Oil in the Topical Therapy of Psoriasis Vulgaris: Dosage Determination

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-11-28
• Last updated: 2019-07-25

Locations

3 sites across 1 country: Taiwan