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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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ClinicalTrials.gov Identifier: NCT03614221
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Lindioil ointment Drug: Protopic ointment 0.1% Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Lindioil
Lindioil ointment is applied twice daily for 6 weeks, followed by a washout period of 1 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. If relapse to IGA ≥ 2 is achieved, the patient is using Protopic ointment 0.1% twice daily for another 6 weeks. If relapse to IGA ≥ 2 is not achievable within 8 weeks after the first treatment period, the subject will terminate participation in this trial.
Drug: Lindioil ointment
Each gram contains 200µg of indirubin. Apply a thin layer of the indicated ointment to the affected skin twice daily for 6 weeks.
Other Name: Indigo naturalis oil extract ointment

Drug: Protopic ointment 0.1%
Each gram contains (w/w) 0.1% of tacrolimus. Apply a thin layer of the indicated ointment to the affected skin twice daily for 6 weeks.
Other Name: Tacrolimus ointment 0.1%

Active Comparator: Protopic
Protopic ointment 0.1% is applied twice daily for 6 weeks, followed by a washout period of 1 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. If relapse to IGA ≥ 2 is achieved, the patient is using Lindioil ointment twice daily for another 6 weeks. If relapse to IGA ≥ 2 is not achievable within 8 weeks after the first treatment period, the subject will terminate participation in this trial.
Drug: Lindioil ointment
Each gram contains 200µg of indirubin. Apply a thin layer of the indicated ointment to the affected skin twice daily for 6 weeks.
Other Name: Indigo naturalis oil extract ointment

Drug: Protopic ointment 0.1%
Each gram contains (w/w) 0.1% of tacrolimus. Apply a thin layer of the indicated ointment to the affected skin twice daily for 6 weeks.
Other Name: Tacrolimus ointment 0.1%




Primary Outcome Measures :
  1. The 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. [ Time Frame: 6 weeks, 13 weeks (the end of the second treatment period) ]
    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 :
  1. 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. [ Time Frame: 6 weeks, 13 weeks (the end of the second treatment period) ]
    It is defined as at least 50%, 75%, and 90% reduction in EASI score compare to the baseline.

  2. 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. [ Time Frame: 6 weeks, 13 weeks (the end of the second 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.

  3. The percentage change from baseline to the end of week 6 of Body Surface Area (BSA, range 0%-100%) affected by AD, for each of the two 6-week treatment periods. [ Time Frame: 6 weeks, 13 weeks (the end of the second treatment period) ]
    BSA is total body surface area affected by atopic dermatitis, ranging from 0% (none) to 100% (total body surface affected).

  4. 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. [ Time Frame: 6 weeks, 13 weeks (the end of the second treatment period) ]
    Length of relapse free days after ceasing treatment

  5. 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. [ Time Frame: 6 weeks, 13 weeks ]
    Numeric Rating Scale for pruritus (NRS) is a tool to evaluate itching intensity from 0 (no itch) to 10 (most imaginable itch)

  6. 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. [ Time Frame: 6 weeks, 13 weeks (the end of the second treatment period) ]
    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.

  7. 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. [ Time Frame: 6 weeks, 13 weeks (the end of the second 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).

  8. The participants' preference of using Lindioil ointment and Protopic® ointment treatment. [ Time Frame: 13 weeks (the end of the second treatment period) ]
    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.

  9. The change of skin microbiome before and after Lindioil ointment and Protopic® ointment treatment. [ Time Frame: 6 weeks, 13 weeks (the end of the second treatment period) ]
    Skin swabs of lesion and non-lesion will be obtained from patient before and after study treatment to analyze skin microbiome.



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614221


Contacts
Contact: Yin-Ku Lin, MD., PhD. 886-2-24313131 ext 2127 lin1266@cgmh.org.tw

Locations
Taiwan
Taipei Chang Gung Memorial Hospital Not yet recruiting
Taipei, Taiwan, 10507
Contact: Yin-Ku Lin, MD., PhD.    886-2-24311311 ext 2127    lin1266@cgmh.org.tw   
Principal Investigator: Yin-Ku Lin, MD., PhD.         
Sub-Investigator: Chun-Bing Chen, MD.         
Sub-Investigator: Chin-Yi Yang, MD.         
Sub-Investigator: Chun-Wei Lu, MD.         
Sub-Investigator: Wen-Hung Chung, MD., PhD.         
Sub-Investigator: Chih-Yung Chiu, MD., PhD         
Sub-Investigator: Shih-Chi Su, PhD.         
Sub-Investigator: Lai-Chu See, PhD.         
Linkou Chang Gung Memorial Hospital Not yet recruiting
Taoyuan, Taiwan, 33305
Contact: Yin-Ku Lin, MD., PhD    886-2-241-3131 ext 2127    lin1266@cgmh.org.tw   
Principal Investigator: Yin-Ku Lin, MD., PhD         
Sub-Investigator: Chun-Bing Chen, MD.         
Sub-Investigator: Chin-Yi Yang, MD.         
Sub-Investigator: Chun-Wei Lu, MD.         
Sub-Investigator: Wen-Hung Chung, MD., PhD         
Sub-Investigator: Chih-Yung Chu, MD., PhD         
Sub-Investigator: Shih-Chi Su, PhD.         
Sub-Investigator: Lai-Chu See, PhD.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
Principal Investigator: Yin-Ku Lin, MD., PhD. Chang Gung Memorial Hospital

Publications:

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03614221     History of Changes
Other Study ID Numbers: 1712140004
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: July 2018

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

Keywords provided by Chang Gung Memorial Hospital:
Atopic Dermatitis
Indigo naturalis
Tacrolimus

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action