Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Yin-ku Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01735864
First received: November 26, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Psoriasis Vulgaris
Drug: Indirubin 200μg/g
Drug: Indirubin 100 μg/g
Drug: Indirubin 50 μg/g
Drug: Indirubin 10 μg/g

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Indigo Naturalis Extract in Oil in the Topical Therapy of Psoriasis Vulgaris: Dosage Determination

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Body surface area (BSA)involved [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    1. Compare the BSA involved change from baseline on target psoriatic lesion(cm2)
    2. Compare the percentage change from baseline on target psoriatic lesion

  • Psoriasis Severity Index (PSI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    1. Mean change of total score (range 0-12) of the target psoriatic plaque
    2. Percentage change of PSI score of the target psoriatic plaque
    3. Clearing percentage of target psoriatic plaque (the target plaque before treatment is defined as 100%, and the clearance of lesion is defined as 0%)

  • Efficacy in various local skin signs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    1. Thickness: thin (<0.05 mm), intermediate (≥0.05 to <1.0 mm) or thick (≥1.0 mm)
    2. Size: small (<5 cm in diameter), large (>5 cm in diameter) or concurrent (i.e., two type sizes exist)
    3. Erythema (redness): light red (ruddier (light red) than peripheral normal skin) or dark red (redder (scarlet) than peripheral normal skin)

  • Efficacy in different traditional Chinese medicine (TCM) clinical syndromes of psoriasis by PASI/PSI: [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    1. Blood-heat (血熱) syndrome
    2. Blood-dryness (血燥) syndrome
    3. Blood-stasis (血瘀) syndrome

  • Physician's Global Assessment (PGA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    0 = no sign of psoriasis, 1 = almost clear, 2 = mild, 3 = moderate, 4 = moderate to severe, and 5 = severe

  • Subject's Global Assessment (SGA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    0 = cleared, 1 = excellent, 2 = good, 3 = fair, 4 = poor, and 5 = worse

  • Dermatology Life Quality Index (DLQI) questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Indirubin 200 μg/g
per gram of ointment contains 200 μg of indirubin
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
Other Name: INEO ointment: Indirubin 200 μg/g
Active Comparator: Indirubin 100 μg/g
per gram of ointment contains 100 μg of indirubin
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
Other Name: INEO ointment: Indirubin 100 μg/g
Active Comparator: Indirubin 50 μg/g
per gram of ointment contains 50 μg of indirubin
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
Other Name: INEO ointment: Indirubin 50 μg/g
Active Comparator: Indirubin 10 μg/g
per gram of ointment contains 10 μg of indirubin
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
Other Name: INEO ointment: Indirubin 10 μg/g

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735864

Locations
Taiwan
Chang Gung Memorial Hospital at Keelung
Keelung, Taiwan
Chang Gung Memorial Hospital at Taipei
Taipei, Taiwan, 105
Chang Gung Memorial Hospital at Linkou
Taoyuan County, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Yin-Ku Lin, MD., PhD. Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung
  More Information

Additional Information:
No publications provided

Responsible Party: Yin-ku Lin, MD., PhD., Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01735864     History of Changes
Other Study ID Numbers: NSC101-2325-B-182-018
Study First Received: November 26, 2012
Last Updated: November 26, 2012
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Chang Gung Memorial Hospital:
Indigo naturalis extract in oil

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Indirubin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014