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Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Lindioil ointment
Protopic ointment 0.1%
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Indigo naturalis, Tacrolimus

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Chang Gung Memorial Hospital
  • Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lindioil

Protopic

Arm Description

Lindioil ointment is applied twice daily for 6 weeks, followed by a washout period of 4 days to 8 weeks depending on the results of the first treatment period and the amount of time it takes the participant to relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA. If relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA is achieved, the patient is using Protopic ointment 0.1% twice daily for another 6 weeks. If the criteria for entering the 2nd treatment are not achievable after 8-week of ceasing 1st treatment, the subject will be followed up for another 6 weeks to the end of the study

Protopic ointment 0.1% is applied twice daily for 6 weeks, followed by a washout period of 4 days to 8 weeks depending on the results of the first treatment period and the amount of time it takes the participant to relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA. If relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA is achieved, the patient is using Lindioil ointment twice daily for another 6 weeks. If the criteria for entering the 2nd treatment are not achievable after 8-week of ceasing 1st treatment, the subject will be followed up for another 6 weeks to the end of the study

Outcomes

Primary Outcome Measures

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.
The Eczema Area and Severity Index (EASI) is used to measure the disease severity of erythema, infiltration/papulation, excoriation, and lichenification each on a scale of 0 to 3 (none to severe) as well as the percentage of disease area on a scale of 0 to 6 for the 4 body regions: head ⁄ neck, upper limbs, trunk and lower limbs. Each body region score is calculated by multiplying the disease severity score by the disease area score and by the multiplier, 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The scores are summed to give the total EASI score, ranging from 0 to a maximum 72.

Secondary Outcome Measures

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.
It is defined as at least 50%, 75%, and 90% reduction in EASI score compare to the baseline.
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.
Investigator's Global Assessment (IGA) is a 6-points scale ranging from 0 (cleared) to 5 (Very severe) for evaluation of the severity of atopic dermatitis.
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.
BSA is total body surface area affected by atopic dermatitis, ranging from 0% (none) to 100% (total body surface affected).
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.
Length of relapse free days after ceasing treatment
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.
Numeric Rating Scale for pruritus (NRS) is a tool to evaluate itching intensity from 0 (no itch) to 10 (most imaginable itch)
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.
The DLQI is a self-administered 10-item questionnaire, ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
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.
Subject's Global Assessment (SGA) is a self-evaluated the change from baseline of their AD condition as 'much better' (0), 'better' (1) , 'slightly better' (2), 'same' (3), 'slightly worse' (4), 'worse' (5) or 'much worse' (6).
The participants' preference of using Lindioil ointment and Protopic® ointment treatment.
Patients who completed the second treatment period will answer which ointment with better efficacy, which with more adverse events, and the adverse event bothering them most.
The change of skin microbiome before and after Lindioil ointment and Protopic® ointment treatment.
Skin swabs of lesion and non-lesion will be obtained from patient before and after study treatment to analyze skin microbiome.

Full Information

First Posted
July 31, 2018
Last Updated
February 8, 2023
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03614221
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aims of this study are: Compare the efficacy of Lindioil ointment and Protopic® ointment in treating atopic dermatitis. Compare the safety of Lindioil ointment and Protopic® ointment in treating atopic dermatitis. Compare the time to relapse after ceasing of treatment of Lindioil ointment and Protopic® ointment. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Indigo naturalis, Tacrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lindioil
Arm Type
Experimental
Arm Description
Lindioil ointment is applied twice daily for 6 weeks, followed by a washout period of 4 days to 8 weeks depending on the results of the first treatment period and the amount of time it takes the participant to relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA. If relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA is achieved, the patient is using Protopic ointment 0.1% twice daily for another 6 weeks. If the criteria for entering the 2nd treatment are not achievable after 8-week of ceasing 1st treatment, the subject will be followed up for another 6 weeks to the end of the study
Arm Title
Protopic
Arm Type
Active Comparator
Arm Description
Protopic ointment 0.1% is applied twice daily for 6 weeks, followed by a washout period of 4 days to 8 weeks depending on the results of the first treatment period and the amount of time it takes the participant to relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA. If relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA is achieved, the patient is using Lindioil ointment twice daily for another 6 weeks. If the criteria for entering the 2nd treatment are not achievable after 8-week of ceasing 1st treatment, the subject will be followed up for another 6 weeks to the end of the study
Intervention Type
Drug
Intervention Name(s)
Lindioil ointment
Other Intervention Name(s)
Indigo naturalis oil extract ointment
Intervention Description
Each gram contains 200µg of indirubin. Apply 0.5 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Protopic ointment 0.1%
Other Intervention Name(s)
Tacrolimus ointment 0.1%
Intervention Description
Each gram contains (w/w) 0.1% of tacrolimus. Apply 0.1 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
Primary Outcome Measure Information:
Title
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.
Description
The Eczema Area and Severity Index (EASI) is used to measure the disease severity of erythema, infiltration/papulation, excoriation, and lichenification each on a scale of 0 to 3 (none to severe) as well as the percentage of disease area on a scale of 0 to 6 for the 4 body regions: head ⁄ neck, upper limbs, trunk and lower limbs. Each body region score is calculated by multiplying the disease severity score by the disease area score and by the multiplier, 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The scores are summed to give the total EASI score, ranging from 0 to a maximum 72.
Time Frame
6-week, 12-week (the end of the second treatment period)
Secondary Outcome Measure Information:
Title
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.
Description
It is defined as at least 50%, 75%, and 90% reduction in EASI score compare to the baseline.
Time Frame
6-week, 12-week (the end of the second treatment period)
Title
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.
Description
Investigator's Global Assessment (IGA) is a 6-points scale ranging from 0 (cleared) to 5 (Very severe) for evaluation of the severity of atopic dermatitis.
Time Frame
6-week, 12-week (the end of the second treatment period)
Title
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.
Description
BSA is total body surface area affected by atopic dermatitis, ranging from 0% (none) to 100% (total body surface affected).
Time Frame
6-week, 12-week (the end of the second treatment period)
Title
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.
Description
Length of relapse free days after ceasing treatment
Time Frame
6-week, 12-week (the end of the second treatment period)
Title
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.
Description
Numeric Rating Scale for pruritus (NRS) is a tool to evaluate itching intensity from 0 (no itch) to 10 (most imaginable itch)
Time Frame
6-week, 12-week (the end of the second treatment period)
Title
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.
Description
The DLQI is a self-administered 10-item questionnaire, ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Time Frame
6-week, 12-week (the end of the second treatment period)
Title
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.
Description
Subject's Global Assessment (SGA) is a self-evaluated the change from baseline of their AD condition as 'much better' (0), 'better' (1) , 'slightly better' (2), 'same' (3), 'slightly worse' (4), 'worse' (5) or 'much worse' (6).
Time Frame
6-week, 12-week (the end of the second treatment period)
Title
The participants' preference of using Lindioil ointment and Protopic® ointment treatment.
Description
Patients who completed the second treatment period will answer which ointment with better efficacy, which with more adverse events, and the adverse event bothering them most.
Time Frame
13 weeks (the end of the second treatment period)
Title
The change of skin microbiome before and after Lindioil ointment and Protopic® ointment treatment.
Description
Skin swabs of lesion and non-lesion will be obtained from patient before and after study treatment to analyze skin microbiome.
Time Frame
6-week, 12-week (the end of the second treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 16 and 65 years old, female or male. Chronic or sub-acute atopic dermatitis fulfilling the United Kingdom (UK) diagnostic criteria of atopic dermatitis. Atopic dermatitis involving 3-40% of BSA at screening and baseline. An IGA score of 2 (mild) to 4 (severe) at screening and baseline. Not supposed to or unwilling to use corticosteroids. Female patients of child-bearing age agree to use effective birth control measures approved by the investigator. Agree to avoid natural and artificial sunlight over-exposure during the study. Willing to comply with study protocol and agree to sign an informed consent form Exclusion Criteria: Acute atopic dermatitis or concurrence of viral or bacterial infection on dermatitis lesion(s). A history of topical or systematic hypersensitivity to indigo naturalis, tacrolimus, or the excipient(s) in the ointment(s). 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. Having used topical therapy (e.g. corticosteroids) for dermatitis within 4 days before the first application of the study medication. Having a significant concurrent disease such as severe uncontrolled chronic disease (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS. 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. Women who are lactating, pregnant or planning to be pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Ku Lin, MD., PhD.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

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Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis

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