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Study to Evaluate the Use of RHT-3201 in SCORAD Reduction in Young Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03907228
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

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

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Dietary Supplement: RHT-3201 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: RHT-3201
Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet)
Dietary Supplement: RHT-3201
PROBIOTIC

Placebo Comparator: Placebo
Dextrose Anhydrous
Dietary Supplement: RHT-3201
PROBIOTIC




Primary Outcome Measures :
  1. Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score [ Time Frame: after 12-week treatment ]

    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 :
  1. Change from baseline in SCORAD total score [ Time Frame: after 4 and 8 week treatment ]

    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)


  2. Change from baseline in SCORAD objective score [ Time Frame: after 4, 8 and 12 week treatment ]

    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


  3. Change from baseline in SCORAD subjective score [ Time Frame: after 4, 8 and 12 week treatment ]

    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


  4. Change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: after 4, 8 and 12 week treatment ]

    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


  5. Proportion of participants achieving at least a 50%, 75% reduction in EASI [ Time Frame: after 12-week treatment ]
    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.

  6. Change in Investigator Global Assessment (IGA) from baseline to Week 4, 8 and 12 [ Time Frame: after 4, 8 and 12 week treatment ]
    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).

  7. Proportion of participants achieving IGA of 0 or 1 with at least two grades of reduction [ Time Frame: after 12-week treatment ]
    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).

  8. Change from baseline in numeric rating scale (NRS) [ Time Frame: after 4, 8 and 12 week treatment ]
    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.

  9. Change from baseline in immunologic blood marker (Total immunoglobulin E (IgE), Eosinophil counts) [ Time Frame: after 12-week treatment ]
    Measuring total IgE and Eosinophil counts in serum (total IgE (KU/L), Eosinophil counts (cells/uL))

  10. Change from baseline n Children's Dermatology Life Quality Index (CDLQI) or Infants Dermatitis Quality of Life index (IDQoL) [ Time Frame: after 4, 8 and 12 week treatment ]
    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.

  11. Change from baseline in Dermatology Family Impact (DFI) [ Time Frame: after 4, 8 and 12 week treatment ]
    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.

  12. Quantity of emollients [ Time Frame: after 4, 8 and 12 week treatment ]
    Measuring quantity of emollients at every visits

  13. Proportion of participants using topical corticosteroids and quantity of topical corticosteroids [ Time Frame: after 4, 8 and 12 week treatment ]
    Proportion of participants using topical corticosteroids during study period and measuring quantity of topical corticosteroids during study

  14. Number of days with or without topical corticosteroids [ Time Frame: after 4, 8 and 12 week treatment ]
    Number of days with or without topical corticosteroids during study period

  15. Drop-out rate using topical corticosteroids [ Time Frame: after 4, 8 and 12 week treatment ]
    Drop-out rates due to use topical corticosteroids

  16. Incidence of adverse event (AE)'s [ Time Frame: From Baseline through Week 12 (entire study) ]
    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).



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients and patients's parents or legal guardian have signed the informed consent.
  2. Aged 1 to 12 years, diagnosed with atopic dermatitis according to Hanifin and Rajka criteria
  3. Patients experienced AD symptoms for at least 6 months
  4. SCORAD index of 20-40, both inclusive

Exclusion Criteria:

  1. Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
  2. 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.)
  3. Medical history of immunodeficiency syndrome, autoimmune disease or malignancy for systemic therapies that modulate the immune system
  4. 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)
  5. Medical history of infectious intestinal disease within 2 weeks before screening
  6. History of hypersensitivity to components contained in study product (Lactobacillus rhamnosus)
  7. 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)
  8. Patients who are considered to be unacceptable in this study under the opinion of the investigator

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): NCT03907228


Contacts
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Contact: Min Jung Kim 821087721492 mjkim90@ildong.com

Locations
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Korea, Republic of
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Investigators
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Principal Investigator: Kui Young Park Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT03907228     History of Changes
Other Study ID Numbers: ID-RHT-O401
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases