Back to resultsIndigo Naturalis in Treating Atopic Dermatitis Topically
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Indigo naturalis ointment
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Indigo Naturalis, Atopic Dermatitis, TCM
Eligibility Criteria
Inclusion Criteria:
- Between 6 and 65 years old, female or male.
- Atopic dermatitis fulfilling the diagnostic criteria of Williams et al.
- Atopic dermatitis involving <40% of BSA. (Base on the BSA result of Screening)
- An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)
- Female patients of child-bearing age with negative pregnancy test at screening.
- Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
- Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0)
- Willing to comply with study protocol and agree to sign an informed consent form.
Exclusion Criteria:
- Having a history of topical or systematical hypersensitivity to indigo naturalis or its excipient (e.g. beeswax) in ointment
- Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
- Having used topical therapy (e.g. topical corticosteroids) for dermatitis within 7 days before the first application of the study medication.
- Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
- Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).
- Women who are lactating, pregnant or preparing to be pregnant.
Sites / Locations
- Chang Gung Memorial Hospital at Keelung
- Chang Gung Memorial Hospital at Taipei
- Chang Gung Memorial Hospital at Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Indigo naturalis ointment
Placebo
Arm Description
Form: ointment Dose: each gram of ointment contains 200µg of indirubin Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Form: ointment Dose: vehicle Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Outcomes
Primary Outcome Measures
Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6
The Eczema Area and Severity Index (EASI) is used to measure the disease severity of erythema, infiltration/papulation, excoriation, and lichenification each on a scale of 0 to 3 (none to severe) as well as the percentage of disease area on a scale of 0 to 6 for the head ⁄ neck, upper limb, trunk and lower limb body regions. Each body region score is calculated by multiplying the disease severity score by the disease area score and by the multiplier. The scores are summed to give the total EASI score, ranging from 0 to a maximum 72.
The mean percentage change in EASI = (EASI baseline-EASI post-treat) / EASI baseline x 100%
Secondary Outcome Measures
Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 6 weeks of treatment
It is defined as at least 50%, 75%, and 90% reduction in EASI score relative to the baseline.
Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5) from baseline to week 6.
Proportion of subjects with an IGA score of 0 (clear) or 1 (almost clear) at week 6.
Proportion of subjects with ≥ 2 point improvement in IGA at week 6.
The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 6.
BSA is total Body Surface Area involved, ranging from 0% (none) to 100% (total body surface involved)
The mean change in pruritus score (10-cm visual analogue scale) from baseline to week 6.
Visual Analogue Scale (VAS) for pruritus severity rates from 0 (no itching) to 10 (very severe itching)
Clinical-immunological correlation between the treatment outcome and the changes in the level of immunoglobin E (IgE), cytokines, eosinophil count, and C-reactive protein (CRP) in the peripheral blood from baseline to week 6.
Measuring the correlations of treatment by EASI score and BSA, with the changes in IgE, eosinophils, cytokines (IL-1β, IL-6, TNF-α…) from baseline to week 6.
The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 6
The DLQI is a self-administered 10-item questionnaire, ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
For subjects from age 6 to age 16, children's DLQI (CDLQI) will used.
Physician's Global Assessment (PGA ) at week 6.
0 = Symptoms cleared or excellent improvement of 90-100%; 1 = Marked improvement of 75-89%; 2 = Moderate improvement of 50-74%; 3 = Slight improvement of 3049%; 4 = No appreciable improvement of 029%; 5 = Worsening of the condition
Subject's Global Assessment (SGA) at week 6.
0 = Symptoms cleared or excellent improvement of 90-100%; 1 = Marked improvement of 75-89%; 2 = Moderate improvement of 50-74%; 3 = Slight improvement of 3049%; 4 = No appreciable improvement of 029%; 5 = Worsening of the condition
Full Information
NCT ID
NCT02669888
First Posted
December 28, 2015
Last Updated
February 13, 2017
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02669888
Brief Title
Indigo Naturalis in Treating Atopic Dermatitis Topically
Official Title
Efficacy and Safety of Topical Indigo Naturalis in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. The aims of this project are:
To evaluate the efficacy of indigo naturalis ointment in treating AD topically;
To evaluate the safety of indigo naturalis ointment in treating AD topically;
To investigate whether indigo naturalis ointment treatment is associated with a change in total IgE, cytokines, eosinophils, and CRP in patients with AD;
To evaluate whether indigo naturalis ointment treatment improves the quality of life in patients with AD.
Detailed Description
Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. AD is characterized by itchy and dry skin that affects approximately 5 to 20% of children in the world. Currently, corticosteroids are the most widely prescribed medication in treating AD; however, there are concerns regarding the side effects such as skin atrophy, telangiectasia, striae, folliculitis and adrenocortical suppression that inhibits growth in children. Many patients and families seek complementary and alternative medications such as traditional Chinese medicine (TCM). In TCM, indigo naturalis has been used to treat various infectious and inflammatory skin diseases for hundreds of years. Ancient TCM literature has recorded that indigo naturalis is also effective in treating facial eczema (AD) in infants.
The aims of this project are: (1) To evaluate the efficacy of indigo naturalis ointment in treating AD topically; (2) To evaluate the safety of indigo naturalis ointment in treating AD topically; (3) To investigate whether indigo naturalis ointment treatment is associated with a change in total IgE, cytokines, eosinophils, and CRP in patients with AD; (4) To evaluate whether indigo naturalis ointment treatment improves the quality of life in patients with AD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Indigo Naturalis, Atopic Dermatitis, TCM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indigo naturalis ointment
Arm Type
Experimental
Arm Description
Form: ointment
Dose: each gram of ointment contains 200µg of indirubin
Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Form: ointment
Dose: vehicle
Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Intervention Type
Drug
Intervention Name(s)
Indigo naturalis ointment
Other Intervention Name(s)
Lindioil ointment
Intervention Description
Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.
Primary Outcome Measure Information:
Title
Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6
Description
The Eczema Area and Severity Index (EASI) is used to measure the disease severity of erythema, infiltration/papulation, excoriation, and lichenification each on a scale of 0 to 3 (none to severe) as well as the percentage of disease area on a scale of 0 to 6 for the head ⁄ neck, upper limb, trunk and lower limb body regions. Each body region score is calculated by multiplying the disease severity score by the disease area score and by the multiplier. The scores are summed to give the total EASI score, ranging from 0 to a maximum 72.
The mean percentage change in EASI = (EASI baseline-EASI post-treat) / EASI baseline x 100%
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 6 weeks of treatment
Description
It is defined as at least 50%, 75%, and 90% reduction in EASI score relative to the baseline.
Time Frame
6 weeks
Title
Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5) from baseline to week 6.
Description
Proportion of subjects with an IGA score of 0 (clear) or 1 (almost clear) at week 6.
Proportion of subjects with ≥ 2 point improvement in IGA at week 6.
Time Frame
6 weeks
Title
The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 6.
Description
BSA is total Body Surface Area involved, ranging from 0% (none) to 100% (total body surface involved)
Time Frame
6 weeks
Title
The mean change in pruritus score (10-cm visual analogue scale) from baseline to week 6.
Description
Visual Analogue Scale (VAS) for pruritus severity rates from 0 (no itching) to 10 (very severe itching)
Time Frame
6 weeks
Title
Clinical-immunological correlation between the treatment outcome and the changes in the level of immunoglobin E (IgE), cytokines, eosinophil count, and C-reactive protein (CRP) in the peripheral blood from baseline to week 6.
Description
Measuring the correlations of treatment by EASI score and BSA, with the changes in IgE, eosinophils, cytokines (IL-1β, IL-6, TNF-α…) from baseline to week 6.
Time Frame
6 weeks
Title
The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 6
Description
The DLQI is a self-administered 10-item questionnaire, ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
For subjects from age 6 to age 16, children's DLQI (CDLQI) will used.
Time Frame
6 weeks
Title
Physician's Global Assessment (PGA ) at week 6.
Description
0 = Symptoms cleared or excellent improvement of 90-100%; 1 = Marked improvement of 75-89%; 2 = Moderate improvement of 50-74%; 3 = Slight improvement of 3049%; 4 = No appreciable improvement of 029%; 5 = Worsening of the condition
Time Frame
6 weeks
Title
Subject's Global Assessment (SGA) at week 6.
Description
0 = Symptoms cleared or excellent improvement of 90-100%; 1 = Marked improvement of 75-89%; 2 = Moderate improvement of 50-74%; 3 = Slight improvement of 3049%; 4 = No appreciable improvement of 029%; 5 = Worsening of the condition
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 6 and 65 years old, female or male.
Atopic dermatitis fulfilling the diagnostic criteria of Williams et al.
Atopic dermatitis involving <40% of BSA. (Base on the BSA result of Screening)
An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)
Female patients of child-bearing age with negative pregnancy test at screening.
Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0)
Willing to comply with study protocol and agree to sign an informed consent form.
Exclusion Criteria:
Having a history of topical or systematical hypersensitivity to indigo naturalis or its excipient (e.g. beeswax) in ointment
Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
Having used topical therapy (e.g. topical corticosteroids) for dermatitis within 7 days before the first application of the study medication.
Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).
Women who are lactating, pregnant or preparing to be pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Ku Lin, MD., PhD.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital at Keelung
City
Kelung
ZIP/Postal Code
204
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital at Taipei
City
Taipei
ZIP/Postal Code
105
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31838180
Citation
Lin YK, Chang SH, Yang CY, See LC, Lee BH, Shih IH. Efficacy and safety of indigo naturalis ointment in Treating Atopic Dermatitis: A randomized clinical trial. J Ethnopharmacol. 2020 Mar 25;250:112477. doi: 10.1016/j.jep.2019.112477. Epub 2019 Dec 12.
Results Reference
derived
Learn more about this trial
Indigo Naturalis in Treating Atopic Dermatitis Topically
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