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

NCT ID: NCT03907228

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2020-05-31

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

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RHT-3201

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

Group Type: EXPERIMENTAL

RHT-3201

Intervention Type: DIETARY_SUPPLEMENT

PROBIOTIC

Placebo

Dextrose Anhydrous

Group Type: PLACEBO_COMPARATOR

RHT-3201

Intervention Type: DIETARY_SUPPLEMENT

PROBIOTIC

Interventions

RHT-3201

PROBIOTIC

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kui Young Park

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min Jung Kim

Role: CONTACT

mjkim90@ildong.com

821087721492

Other Identifiers

ID-RHT-O401

Identifier Type: -

Identifier Source: org_study_id