Clinical trial NCT01735864: Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment
Official title: Evaluation of the Efficacy and Safety of Indigo Naturalis Extract in Oil in the Topical Therapy of Psoriasis Vulgaris: Dosage Determination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Keywords: Indigo naturalis extract in oil
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups
timeFrame: 8 weeks
Secondary outcomes:
measure: Body surface area (BSA)involved
timeFrame: 8 weeks
measure: Psoriasis Severity Index (PSI)
timeFrame: 8 weeks
measure: Efficacy in various local skin signs
timeFrame: 8 weeks
measure: Efficacy in different traditional Chinese medicine (TCM) clinical syndromes of psoriasis by PASI/PSI:
timeFrame: 8 weeks
measure: Physician's Global Assessment (PGA)
timeFrame: 8 weeks
measure: Subject's Global Assessment (SGA)
timeFrame: 8 weeks
measure: Dermatology Life Quality Index (DLQI) questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital at Keelung
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital at Taipei
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
Study officials:
affiliation: Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung
name: Yin-Ku Lin, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: