Indigo Naturalis in Treating Atopic Dermatitis Topically

NCT ID: NCT02669888

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-02-28

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.

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Indigo naturalis ointment

Intervention Type: DRUG

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.

Placebo

1. Form: ointment

2. Dose: vehicle

3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Lindioil ointment

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yin-Ku Lin, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital at Keelung

Kelung, Taiwan, Taiwan

Chang Gung Memorial Hospital at Taipei

Taipei, Taiwan, Taiwan

Chang Gung Memorial Hospital at Linkou

Taoyuan District, Taiwan, Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 31838180 (View on PubMed)

Other Identifiers

MOST 104-2325-B-182A-005

Identifier Type: -

Identifier Source: org_study_id