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Indigo Naturalis in Treating Atopic Dermatitis Topically

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ClinicalTrials.gov Identifier: NCT02669888
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Indigo naturalis ointment Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Indigo Naturalis in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Actual Study Start Date : October 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Indigo naturalis ointment
  1. Form: ointment
  2. Dose: each gram of ointment contains 200µg of indirubin
  3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Drug: Indigo naturalis ointment
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.
Other Name: Lindioil ointment

Placebo Comparator: Placebo
  1. Form: ointment
  2. Dose: vehicle
  3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Drug: Placebo
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 Measures :
  1. Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6 [ Time Frame: 6 weeks ]

    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 :
  1. Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 6 weeks of treatment [ Time Frame: 6 weeks ]
    It is defined as at least 50%, 75%, and 90% reduction in EASI score relative to the baseline.

  2. Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5) from baseline to week 6. [ Time Frame: 6 weeks ]
    1. Proportion of subjects with an IGA score of 0 (clear) or 1 (almost clear) at week 6.
    2. Proportion of subjects with ≥ 2 point improvement in IGA at week 6.

  3. The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 6. [ Time Frame: 6 weeks ]
    BSA is total Body Surface Area involved, ranging from 0% (none) to 100% (total body surface involved)

  4. The mean change in pruritus score (10-cm visual analogue scale) from baseline to week 6. [ Time Frame: 6 weeks ]
    Visual Analogue Scale (VAS) for pruritus severity rates from 0 (no itching) to 10 (very severe itching)

  5. 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. [ Time Frame: 6 weeks ]
    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.

  6. The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 6 [ Time Frame: 6 weeks ]

    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.


  7. Physician's Global Assessment (PGA ) at week 6. [ Time Frame: 6 weeks ]
    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

  8. Subject's Global Assessment (SGA) at week 6. [ Time Frame: 6 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 6 and 65 years old, female or male.
  2. Atopic dermatitis fulfilling the diagnostic criteria of Williams et al.
  3. Atopic dermatitis involving <40% of BSA. (Base on the BSA result of Screening)
  4. 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)
  5. Female patients of child-bearing age with negative pregnancy test at screening.
  6. 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.
  7. Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0)
  8. Willing to comply with study protocol and agree to sign an informed consent form.

Exclusion Criteria:

  1. Having a history of topical or systematical hypersensitivity to indigo naturalis or its excipient (e.g. beeswax) in ointment
  2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
  3. Having used topical therapy (e.g. topical corticosteroids) for dermatitis within 7 days before the first application of the study medication.
  4. 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.
  5. Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).
  6. Women who are lactating, pregnant or preparing to be pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669888


Locations
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Taiwan
Chang Gung Memorial Hospital at Keelung
Kelung, Taiwan, 204
Chang Gung Memorial Hospital at Taipei
Taipei, Taiwan, 105
Chang Gung Memorial Hospital at Linkou
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Yin-Ku Lin, MD., PhD. Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02669888     History of Changes
Other Study ID Numbers: MOST 104-2325-B-182A-005
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chang Gung Memorial Hospital:
Indigo Naturalis
Atopic Dermatitis
TCM

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases