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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
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.
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.
Taipei Chang Gung Memorial Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
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.
Time frame: 6-week, 12-week (the end of the second treatment period)
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.
Time frame: 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.
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)
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).
Time frame: 6-week, 12-week (the end of the second treatment period)
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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
Time frame: 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.
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)
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.
Time frame: 6-week, 12-week (the end of the second treatment period)
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).
Time frame: 6-week, 12-week (the end of the second treatment period)
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.
Time frame: 13 weeks (the end of the second treatment period)
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.
Time frame: 6-week, 12-week (the end of the second treatment period)