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

NCT03614221 | Completed Phase 2

• 1 other identifier: MOST107-2320-B-182A-002 -MY3
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

The aims of this study are:

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

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Indigo naturalis; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• 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.

  6-week, 12-week (the end of the second treatment period)

Secondary Outcomes (9)

• 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.

  6-week, 12-week (the end of the second treatment period)

• 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.

  6-week, 12-week (the end of the second treatment period)

• 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.

  6-week, 12-week (the end of the second treatment period)

• 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.

  6-week, 12-week (the end of the second treatment period)

• 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.

  6-week, 12-week (the end of the second treatment period)

Study Arms (2)

Lindioil

EXPERIMENTAL

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

Drug: Lindioil ointment; Drug: Protopic ointment 0.1%

Protopic

ACTIVE COMPARATOR

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

Drug: Lindioil ointment; Drug: Protopic ointment 0.1%

Interventions

Lindioil ointment DRUG

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.

Also known as: Indigo naturalis oil extract ointment

Lindioil; Protopic

Protopic ointment 0.1% DRUG

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.

Also known as: Tacrolimus ointment 0.1%

Lindioil; Protopic

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (2)

Taipei Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

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MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yin-Ku Lin, MD., PhD.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 3, 2018
• Study Start: June 3, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 6, 2021
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

TW (2)