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

NCT03907228 | Unknown

• 1 other identifier: ID-RHT-O401
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  after 12-week treatment

Secondary Outcomes (16)

• Change from baseline in SCORAD total score

  after 4 and 8 week treatment

• Change from baseline in SCORAD objective score

  after 4, 8 and 12 week treatment

• Change from baseline in SCORAD subjective score

  after 4, 8 and 12 week treatment

• Change from baseline in Eczema Area and Severity Index (EASI)

  after 4, 8 and 12 week treatment

• Proportion of participants achieving at least a 50%, 75% reduction in EASI

  after 12-week treatment

Study Arms (2)

RHT-3201

EXPERIMENTAL

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

Dietary Supplement: RHT-3201

Placebo

PLACEBO COMPARATOR

Dextrose Anhydrous

Dietary Supplement: RHT-3201

Interventions

RHT-3201 DIETARY_SUPPLEMENT

PROBIOTIC

Placebo; RHT-3201

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
• 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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kui Young Park

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Jung Kim

CONTACT

821087721492; mjkim90@ildong.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple (Participant, Care Provider, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 8, 2019
• Study Start: March 15, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)