Clinical trial NCT02669888: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Indigo Naturalis
Atopic Dermatitis
TCM
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2016-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 6 weeks of treatment
timeFrame: 6 weeks
measure: Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5) from baseline to week 6.
timeFrame: 6 weeks
measure: The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 6.
timeFrame: 6 weeks
measure: The mean change in pruritus score (10-cm visual analogue scale) from baseline to week 6.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 6
timeFrame: 6 weeks
measure: Physician's Global Assessment (PGA ) at week 6.
timeFrame: 6 weeks
measure: Subject's Global Assessment (SGA) at week 6.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kelung
country: Taiwan
facility: Chang Gung Memorial Hospital at Keelung
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital at Taipei
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yin-Ku Lin, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.