Clinical trial NCT03614221: Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis
Official title: Comparison of the Efficacy and Safety of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® (Tacrolimus 0.1%) Ointment in Treating Atopic Dermatitis: A Randomized, Evaluator-blind, Crossover, Active-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Indigo naturalis
Tacrolimus
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2018-08-03
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aims of this study are:

1. Compare the efficacy of Lindioil ointment and Protopic® ointment in treating atopic dermatitis.
2. Compare the safety of Lindioil ointment and Protopic® ointment in treating atopic dermatitis.
3. Compare the time to relapse after ceasing of treatment of Lindioil ointment and Protopic® ointment.
4. Compare the change of skin microbiome before and after Lindioil ointment and Protopic® ointment treatment.

Detailed description: Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by itchiness. Topical corticosteroids are typically used to treat AD. However, many patients have concerns about the safety of long-term use, and seek alternative therapies 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. The investigate also found that the results of indigo naturalis ointment treatment in other trial were comparable to the results of calcineurin inhibitor (such as Tacrolimus) treatment, and would like to verify this assertion. The aim of this study is to compare the efficacy of Lindioil ointment with that of Protopic® (Tacrolimus ointment 0.1%) in treating AD.

Eligibility criteria: Inclusion Criteria:

1. Between 16 and 65 years old, female or male.
2. Chronic or sub-acute atopic dermatitis fulfilling the United Kingdom (UK) diagnostic criteria of atopic dermatitis.
3. Atopic dermatitis involving 3-40% of BSA at screening and baseline.
4. An IGA score of 2 (mild) to 4 (severe) at screening and baseline.
5. Not supposed to or unwilling to use corticosteroids.
6. Female patients of child-bearing age agree to use effective birth control measures approved by the investigator.
7. Agree to avoid natural and artificial sunlight over-exposure during the study.
8. Willing to comply with study protocol and agree to sign an informed consent form

Exclusion Criteria:

1. Acute atopic dermatitis or concurrence of viral or bacterial infection on dermatitis lesion(s).
2. A history of topical or systematic hypersensitivity to indigo naturalis, tacrolimus, or the excipient(s) in the ointment(s).
3. Having received systemic therapy (e.g. immunosuppressive agents) within 14 days, or phototherapy (e.g.

   ultraviolet B (UVB), psoralen and ultraviolet A (PUVA)) within 42 days before the first application of the study medication.
4. Having used topical therapy (e.g. corticosteroids) for dermatitis within 4 days before the first application of the study medication.
5. Having a significant concurrent disease such as severe uncontrolled chronic disease (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
6. Having significant abnormal liver or renal function (Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) \>3 x upper limit of normal (ULN), creatinine \>2.0 mg/dl) or clinically significant abnormal hematological lab result, according to investigator's judgment, on the safety lab test to be performed within 30 days before the baseline visit.
7. Women who are lactating, pregnant or planning to be pregnant during the study.

Primary outcomes:
measure: The mean percentage change from baseline to the end of week 6 of Eczema Area Severity Index (EASI) scores (range 0-72), for each of the two 6-week treatment periods.
timeFrame: 6-week, 12-week (the end of the second treatment period)
Secondary outcomes:
measure: Proportion of participants who have achieved a 50%, 75% and 90% improvement in EASI scores (EASI-50, EASI-75 and EASI-90, respectively) at the end of week 6 of each treatment period.
timeFrame: 6-week, 12-week (the end of the second treatment period)
measure: Proportion of participants with an Investigator's Global Assessment (IGA, 0-5) score of 0 (clear) or 1 (almost clear) at the end of week 6 of each treatment period.
timeFrame: 6-week, 12-week (the end of the second treatment period)
measure: The mean percentage change from baseline to the end of week 6 of the Body Surface Area (BSA, range 0%-100%) affected by AD, for each of the two 6-week treatment periods.
timeFrame: 6-week, 12-week (the end of the second treatment period)
measure: Number of days until relapse to IGA ≥ 2, after ceasing treatment, for subjects who achieved IGA 0 or 1 at the end of week 6 of each treatment period.
timeFrame: 6-week, 12-week (the end of the second treatment period)
measure: The change from baseline to the end of week 6 of Numeric Rating Scale for pruritus (NRS, 0-10), for each of the two 6-week treatment periods.
timeFrame: 6-week, 12-week (the end of the second treatment period)
measure: The change from baseline to the end of week 6 of Dermatology Life Quality Index (DLQI) for each of the two 6-week treatment periods.
timeFrame: 6-week, 12-week (the end of the second treatment period)
measure: Proportion of participants with a Subject's Global Assessment (SGA, 0-6) score of 0 (much better) or 1 (better) at the end of week 6 of each treatment period.
timeFrame: 6-week, 12-week (the end of the second treatment period)
measure: The participants' preference of using Lindioil ointment and Protopic® ointment treatment.
timeFrame: 13 weeks (the end of the second treatment period)
measure: The change of skin microbiome before and after Lindioil ointment and Protopic® ointment treatment.
timeFrame: 6-week, 12-week (the end of the second treatment period)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yin-Ku Lin, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
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