Indigo Naturalis in Treating Atopic Dermatitis Topically

Chang Gung Medical Foundation

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Indigo naturalis ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT02669888

MOST 104-2325-B-182A-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 6 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Indigo naturalis ointment

Experimental group

Description:

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

Treatment:

Drug: Indigo naturalis ointment

Placebo

Placebo Comparator group

Description:

1. Form: ointment 2. Dose: vehicle 3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily

Treatment:

Drug: Placebo