Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional

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.
    

Intervention name(s): Indirubin 200μg/g; Indirubin 100 μg/g; Indirubin 50 μg/g; Indirubin 10 μg/g
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dosage form: Ointment
Dose(s): Each gram of ointment containing 200 μg of indirubin
Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily; Dosage form: Ointment
Dose(s): Each gram of ointment contains 100 μg of indirubin
Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily; Dosage form: Ointment
Dose(s): Each gram of ointment contains 50 μg of indirubin
Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily; Dosage form: Ointment
Dose(s): Each gram of ointment contains 10 μg of indirubin
Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily
Other intervention name(s): INEO ointment: Indirubin 200 μg/g; INEO ointment: Indirubin 100 μg/g; INEO ointment: Indirubin 50 μg/g; INEO ointment: Indirubin 10 μg/g
Intervention MeSH terms: Indirubin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Indigo naturalis extract in oil