Back to resultsStudy to Evaluate the Use of RHT-3201 in SCORAD Reduction in Young Patients With Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RHT-3201
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
Eligibility Criteria
Inclusion Criteria:
- Patients and patients's parents or legal guardian have signed the informed consent.
- Aged 1 to 12 years, diagnosed with atopic dermatitis according to Hanifin and Rajka criteria
- Patients experienced AD symptoms for at least 6 months
- SCORAD index of 20-40, both inclusive
Exclusion Criteria:
- Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
- Active cutaneous or extracutaneous infection (bacterial, viral, fungal) requiring systemic treatment within 2 weeks of baseline (Localized molluscum contagiosum with <20 lesions and viral warts are generally not reasons for exclusion.)
- Medical history of immunodeficiency syndrome, autoimmune disease or malignancy for systemic therapies that modulate the immune system
Use of medications or treatments before baseline
- Treated with corticosteroids, immunosuppressive treatment within 4 weeks of baseline
- Treated with herbal medicines and health functional foods related to atopic dermatitis within 4 weeks of baseline
- Treated with phototherapy treatments to atopic dermatitis within 4 weeks of baseline
- Treated with probiotics within 4 weeks of baseline
- Treated with systemic antibiotics within 2 weeks of baseline
- Treated with topical steroids, topical immunomodulators, oral antihistamines, and topical antibiotic within 1 week of baseline (inhaled corticosteroids for asthma, no washout required if doses is stable)
- Medical history of infectious intestinal disease within 2 weeks before screening
- History of hypersensitivity to components contained in study product (Lactobacillus rhamnosus)
- Participation in any other investigational drug study in which receipt of an investigational study drug or health functional food within the past 4 weeks before screening (or, if known, administered within 5 times the half-life)
- Patients who are considered to be unacceptable in this study under the opinion of the investigator
Sites / Locations
- Chung-Ang University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RHT-3201
Placebo
Arm Description
Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet)
Dextrose Anhydrous
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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
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
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
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.
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).
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).
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.
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))
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.
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.
Quantity of emollients
Measuring quantity of emollients at every visits
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
Number of days with or without topical corticosteroids
Number of days with or without topical corticosteroids during study period
Drop-out rate using topical corticosteroids
Drop-out rates due to use topical corticosteroids
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).
Full Information
NCT ID
NCT03907228
First Posted
April 4, 2019
Last Updated
April 4, 2019
Sponsor
IlDong Pharmaceutical Co Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03907228
Brief Title
Study to Evaluate the Use of RHT-3201 in SCORAD Reduction in Young Patients With Atopic Dermatitis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of RHT-3201 for the Evaluation of Efficacy and Safety on the Children With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple (Participant, Care Provider, Investigator)
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RHT-3201
Arm Type
Experimental
Arm Description
Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dextrose Anhydrous
Intervention Type
Dietary Supplement
Intervention Name(s)
RHT-3201
Intervention Description
PROBIOTIC
Primary Outcome Measure Information:
Title
Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in SCORAD total score
Description
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
Title
Change from baseline in SCORAD objective score
Description
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
Title
Change from baseline in SCORAD subjective score
Description
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
Title
Change from baseline in Eczema Area and Severity Index (EASI)
Description
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
Title
Proportion of participants achieving at least a 50%, 75% reduction in EASI
Description
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
Title
Change in Investigator Global Assessment (IGA) from baseline to Week 4, 8 and 12
Description
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
Title
Proportion of participants achieving IGA of 0 or 1 with at least two grades of reduction
Description
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
Title
Change from baseline in numeric rating scale (NRS)
Description
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
Title
Change from baseline in immunologic blood marker (Total immunoglobulin E (IgE), Eosinophil counts)
Description
Measuring total IgE and Eosinophil counts in serum (total IgE (KU/L), Eosinophil counts (cells/uL))
Time Frame
after 12-week treatment
Title
Change from baseline n Children's Dermatology Life Quality Index (CDLQI) or Infants Dermatitis Quality of Life index (IDQoL)
Description
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
Title
Change from baseline in Dermatology Family Impact (DFI)
Description
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
Title
Quantity of emollients
Description
Measuring quantity of emollients at every visits
Time Frame
after 4, 8 and 12 week treatment
Title
Proportion of participants using topical corticosteroids and quantity of topical corticosteroids
Description
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
Title
Number of days with or without topical corticosteroids
Description
Number of days with or without topical corticosteroids during study period
Time Frame
after 4, 8 and 12 week treatment
Title
Drop-out rate using topical corticosteroids
Description
Drop-out rates due to use topical corticosteroids
Time Frame
after 4, 8 and 12 week treatment
Title
Incidence of adverse event (AE)'s
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients and patients's parents or legal guardian have signed the informed consent.
Aged 1 to 12 years, diagnosed with atopic dermatitis according to Hanifin and Rajka criteria
Patients experienced AD symptoms for at least 6 months
SCORAD index of 20-40, both inclusive
Exclusion Criteria:
Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
Active cutaneous or extracutaneous infection (bacterial, viral, fungal) requiring systemic treatment within 2 weeks of baseline (Localized molluscum contagiosum with <20 lesions and viral warts are generally not reasons for exclusion.)
Medical history of immunodeficiency syndrome, autoimmune disease or malignancy for systemic therapies that modulate the immune system
Use of medications or treatments before baseline
Treated with corticosteroids, immunosuppressive treatment within 4 weeks of baseline
Treated with herbal medicines and health functional foods related to atopic dermatitis within 4 weeks of baseline
Treated with phototherapy treatments to atopic dermatitis within 4 weeks of baseline
Treated with probiotics within 4 weeks of baseline
Treated with systemic antibiotics within 2 weeks of baseline
Treated with topical steroids, topical immunomodulators, oral antihistamines, and topical antibiotic within 1 week of baseline (inhaled corticosteroids for asthma, no washout required if doses is stable)
Medical history of infectious intestinal disease within 2 weeks before screening
History of hypersensitivity to components contained in study product (Lactobacillus rhamnosus)
Participation in any other investigational drug study in which receipt of an investigational study drug or health functional food within the past 4 weeks before screening (or, if known, administered within 5 times the half-life)
Patients who are considered to be unacceptable in this study under the opinion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Jung Kim
Phone
821087721492
Email
mjkim90@ildong.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kui Young Park
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Use of RHT-3201 in SCORAD Reduction in Young Patients With Atopic Dermatitis
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