Clinical trial NCT03907228: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dermatitis, Atopic
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score
timeFrame: after 12-week treatment
Secondary outcomes:
measure: Change from baseline in SCORAD total score
timeFrame: after 4 and 8 week treatment
measure: Change from baseline in SCORAD objective score
timeFrame: after 4, 8 and 12 week treatment
measure: Change from baseline in SCORAD subjective score
timeFrame: after 4, 8 and 12 week treatment
measure: Change from baseline in Eczema Area and Severity Index (EASI)
timeFrame: after 4, 8 and 12 week treatment
measure: Proportion of participants achieving at least a 50%, 75% reduction in EASI
timeFrame: after 12-week treatment
measure: Change in Investigator Global Assessment (IGA) from baseline to Week 4, 8 and 12
timeFrame: after 4, 8 and 12 week treatment
measure: Proportion of participants achieving IGA of 0 or 1 with at least two grades of reduction
timeFrame: after 12-week treatment
measure: Change from baseline in numeric rating scale (NRS)
timeFrame: after 4, 8 and 12 week treatment
measure: Change from baseline in immunologic blood marker (Total immunoglobulin E (IgE), Eosinophil counts)
timeFrame: after 12-week treatment
measure: Change from baseline n Children's Dermatology Life Quality Index (CDLQI) or Infants Dermatitis Quality of Life index (IDQoL)
timeFrame: after 4, 8 and 12 week treatment
measure: Change from baseline in Dermatology Family Impact (DFI)
timeFrame: after 4, 8 and 12 week treatment
measure: Quantity of emollients
timeFrame: after 4, 8 and 12 week treatment
measure: Proportion of participants using topical corticosteroids and quantity of topical corticosteroids
timeFrame: after 4, 8 and 12 week treatment
measure: Number of days with or without topical corticosteroids
timeFrame: after 4, 8 and 12 week treatment
measure: Drop-out rate using topical corticosteroids
timeFrame: after 4, 8 and 12 week treatment
measure: Incidence of adverse event (AE)'s
timeFrame: From Baseline through Week 12 (entire study)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Kui Young Park
role: PRINCIPAL_INVESTIGATOR
References: