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

IlDong Pharmaceutical

Status: Unknown

Conditions: Dermatitis, Atopic

Treatments: Dietary Supplement: RHT-3201

Study type: Interventional

Funder types: Industry

Identifiers

NCT03907228

ID-RHT-O401

Details and patient eligibility

About

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

Enrollment: 102 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

RHT-3201

Experimental group

Description:

Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet)

Treatment:

Dietary Supplement: RHT-3201

Placebo

Placebo Comparator group

Description:

Dextrose Anhydrous

Treatment:

Dietary Supplement: RHT-3201