An interventional study of RHT-3201 in Dermatitis, Atopic, sponsored by IlDong Pharmaceutical Co Ltd. Status unknown at 1 site in South Korea. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by IlDong Pharmaceutical Co Ltd · Not applicable, Interventional, and Treatment
The study's objective is to confirm that RHT-3201 reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 1 to 12 years, as compared to placebo. It will also be examined if the RHT-3201 treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's planned enrollment of 102 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →IlDong Pharmaceutical Co Ltd is the lead sponsor of 50 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Use of medications or treatments before baseline
Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet)
Dietary Supplement: RHT-3201
Dextrose Anhydrous
Dietary Supplement: RHT-3201
PROBIOTIC
Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score
Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
Time frame: after 12-week treatment
Change from baseline in SCORAD total score
Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)
Time frame: after 4 and 8 week treatment
Change from baseline in SCORAD objective score
Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome) "Objective" SCORAD, which is composed of part A and B of the SCORAD
Time frame: after 4, 8 and 12 week treatment
Change from baseline in SCORAD subjective score
Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome) "Subjective" SCORAD, which is composed of part C of the SCORAD
Time frame: after 4, 8 and 12 week treatment
Change from baseline in Eczema Area and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. Scores range is 0-72 and Higher values represent a worse outcome
Time frame: after 4, 8 and 12 week treatment
Proportion of participants achieving at least a 50%, 75% reduction in EASI
EASI 50 or EASI 75 responder rates, defined as proportions of patients achieving 50% or more and 75% or more improvement in EASI score from baseline, respectively.
Time frame: after 12-week treatment
Change in Investigator Global Assessment (IGA) from baseline to Week 4, 8 and 12
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 6-point scale ranging from 0 (clear) to 5 (Very severe disease).
Time frame: after 4, 8 and 12 week treatment
Proportion of participants achieving IGA of 0 or 1 with at least two grades of reduction
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 6-point scale ranging from 0 (clear) to 5 (Very severe disease).
Time frame: after 12-week treatment
Change from baseline in numeric rating scale (NRS)
Participant-rated pruritus score of lesions and insomnia rated the severity of pruritus suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no pruritus and 10 is most severe possible pruritus.
Time frame: after 4, 8 and 12 week treatment
Change from baseline in immunologic blood marker (Total immunoglobulin E (IgE), Eosinophil counts)
Measuring total IgE and Eosinophil counts in serum (total IgE (KU/L), Eosinophil counts (cells/uL))
Time frame: after 12-week treatment
Change from baseline n Children's Dermatology Life Quality Index (CDLQI) or Infants Dermatitis Quality of Life index (IDQoL)
The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time frame: after 4, 8 and 12 week treatment
Change from baseline in Dermatology Family Impact (DFI)
The DFI is a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It is completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question is scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score is the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.
Time frame: after 4, 8 and 12 week treatment
Quantity of emollients
Measuring quantity of emollients at every visits
Time frame: after 4, 8 and 12 week treatment
Proportion of participants using topical corticosteroids and quantity of topical corticosteroids
Proportion of participants using topical corticosteroids during study period and measuring quantity of topical corticosteroids during study
Time frame: after 4, 8 and 12 week treatment
Number of days with or without topical corticosteroids
Number of days with or without topical corticosteroids during study period
Time frame: after 4, 8 and 12 week treatment
Drop-out rate using topical corticosteroids
Drop-out rates due to use topical corticosteroids
Time frame: after 4, 8 and 12 week treatment
Incidence of adverse event (AE)'s
AE will be assessed by incidence of AE, abnormalities in vital sign assessments, clinical laboratory assessments, and physical exams Incidence of treatment emergent AEs. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild (AEs does not interfere with participant's usual function); b) moderate (AEs interferes to some extent with participant's usual function) and c) severe (AEs interferes significantly with participant's usual function).
Time frame: From Baseline through Week 12 (entire study)
Plan to share: No
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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