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

Last updated: April 4, 2019
Sponsor: IlDong Pharmaceutical Co Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Hives (Urticaria)

Eczema (Atopic Dermatitis - Pediatric)

Treatment

N/A

Clinical Study ID

NCT03907228
ID-RHT-O401
  • Ages 1-12
  • All Genders

Study 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

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 Rajkacriteria

  3. Patients experienced AD symptoms for at least 6 months

  4. SCORAD index of 20-40, both inclusive

Exclusion

Exclusion Criteria:

  1. Patient has other active non-AD skin diseases that could difficult the atopicdermatitis evaluation

  2. Active cutaneous or extracutaneous infection (bacterial, viral, fungal) requiringsystemic 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 forsystemic therapies that modulate the immune system

  4. Use of medications or treatments before baseline

  • Treated with corticosteroids, immunosuppressive treatment within 4 weeks ofbaseline

  • Treated with herbal medicines and health functional foods related to atopicdermatitis within 4 weeks of baseline

  • Treated with phototherapy treatments to atopic dermatitis within 4 weeks ofbaseline

  • 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, andtopical antibiotic within 1 week of baseline (inhaled corticosteroids for asthma,no washout required if doses is stable)

  1. Medical history of infectious intestinal disease within 2 weeks before screening

  2. History of hypersensitivity to components contained in study product (Lactobacillusrhamnosus)

  3. Participation in any other investigational drug study in which receipt of aninvestigational study drug or health functional food within the past 4 weeks beforescreening (or, if known, administered within 5 times the half-life)

  4. Patients who are considered to be unacceptable in this study under the opinion of theinvestigator

Study Design

Total Participants: 102
Study Start date:
March 15, 2019
Estimated Completion Date:
May 31, 2020

Connect with a study center

  • Chung-Ang University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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