Indigo Naturalis in Treating Atopic Dermatitis Topically

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: Ministry of Science and Technology, Taiwan

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.