Dermatitis, AtopicNCT03907228
Study to Evaluate the Use of RHT-3201 in SCORAD Reduction in Young Patients With Atopic Dermatitis
A study testing RHT-3201 in people with Dermatitis, Atopic, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- RHT-3201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
- 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.)
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul
About this study
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
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
- Being tested
- RHT-3201
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHT-3201Dietary supplement
PROBIOTIC
| Study group | Role | What they receive |
|---|---|---|
| RHT-3201 | Experimental | Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet) Receives: Dietary Supplement: RHT-3201 |
| Placebo | Placebo comparator | Dextrose Anhydrous Receives: Dietary Supplement: RHT-3201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: after 12-week treatment
Secondary outcomes (16)
Change from baseline in 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)
Measured: after 4 and 8 week treatment
Change from baseline in SCORAD objective 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) "Objective" SCORAD, which is composed of part A and B of the SCORAD
Measured: after 4, 8 and 12 week treatment
Change from baseline in SCORAD subjective 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) "Subjective" SCORAD, which is composed of part C of the SCORAD
Measured: after 4, 8 and 12 week treatment
Change from baseline in Eczema Area and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
Scores range is 0-72 and Higher values represent a worse outcome
Measured: after 4, 8 and 12 week treatment
Proportion of participants achieving at least a 50%, 75% reduction in EASI
EASI 50 or EASI 75 responder rates, defined as proportions of patients achieving 50% or more and 75% or more improvement in EASI score from baseline, respectively.
Measured: after 12-week treatment
Change in Investigator Global Assessment (IGA) from baseline to Week 4, 8 and 12
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 6-point scale ranging from 0 (clear) to 5 (Very severe disease).
Measured: after 4, 8 and 12 week treatment
Proportion of participants achieving IGA of 0 or 1 with at least two grades of reduction
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 6-point scale ranging from 0 (clear) to 5 (Very severe disease).
Measured: after 12-week treatment
Change from baseline in numeric rating scale (NRS)
Participant-rated pruritus score of lesions and insomnia rated the severity of pruritus suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no pruritus and 10 is most severe possible pruritus.
Measured: after 4, 8 and 12 week treatment
Change from baseline in immunologic blood marker (Total immunoglobulin E (IgE), Eosinophil counts)
Measuring total IgE and Eosinophil counts in serum (total IgE (KU/L), Eosinophil counts (cells/uL))
Measured: after 12-week treatment
Change from baseline n Children's Dermatology Life Quality Index (CDLQI) or Infants Dermatitis Quality of Life index (IDQoL)
The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Measured: after 4, 8 and 12 week treatment
Change from baseline in Dermatology Family Impact (DFI)
The DFI is a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It is completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question is scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score is the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.
Measured: after 4, 8 and 12 week treatment
Quantity of emollients
Measuring quantity of emollients at every visits
Measured: after 4, 8 and 12 week treatment
Proportion of participants using topical corticosteroids and quantity of topical corticosteroids
Proportion of participants using topical corticosteroids during study period and measuring quantity of topical corticosteroids during study
Measured: after 4, 8 and 12 week treatment
Number of days with or without topical corticosteroids
Number of days with or without topical corticosteroids during study period
Measured: after 4, 8 and 12 week treatment
Drop-out rate using topical corticosteroids
Drop-out rates due to use topical corticosteroids
Measured: after 4, 8 and 12 week treatment
Incidence of adverse event (AE)'s
AE will be assessed by incidence of AE, abnormalities in vital sign assessments, clinical laboratory assessments, and physical exams Incidence of treatment emergent AEs. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild (AEs does not interfere with participant's usual function); b) moderate (AEs interferes to some extent with participant's usual function) and c) severe (AEs interferes significantly with participant's usual function).
Measured: From Baseline through Week 12 (entire study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start15 Mar 2019
- Primary completionApr 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kui Young Park, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907228
- Sponsor's protocol ID
- ID-RHT-O401
- Status last verified
- Mar 2019
- First submitted
- 4 Apr 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03907228
- Acronym / sponsor ID
- ID-RHT-O401
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHT-3201 | Experimental | Dietary Supplement: RHT-3201Lactobacillus rhamnosus IDCC 3201, Tyndallization (RHT-3201) (100 billion Colony Forming Units/sachet) |
| Placebo | Placebo comparator | Dietary Supplement: RHT-3201Dextrose Anhydrous |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Patient has other active non-AD skin diseases that could difficult the atopic dermatitis evaluation
- 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.)
- Medical history of immunodeficiency syndrome, autoimmune disease or malignancy for systemic therapies that modulate the immune system
- Use of medications or treatments before baseline
- Medical history of infectious intestinal disease within 2 weeks before screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHT-3201PROBIOTIC | Dietary supplement | Placebo, RHT-3201 |
Primary outcome
Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score
Time frame: after 12-week treatment
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)
16 secondary outcomes
Change from baseline in SCORAD total score
Time frame: after 4 and 8 week treatment
Change from baseline in SCORAD objective score
Time frame: after 4, 8 and 12 week treatment
Change from baseline in SCORAD subjective score
Time frame: after 4, 8 and 12 week treatment
Change from baseline in Eczema Area and Severity Index (EASI)
Time frame: after 4, 8 and 12 week treatment
Proportion of participants achieving at least a 50%, 75% reduction in EASI
Time frame: after 12-week treatment
Change in Investigator Global Assessment (IGA) from baseline to Week 4, 8 and 12
Time frame: after 4, 8 and 12 week treatment
Proportion of participants achieving IGA of 0 or 1 with at least two grades of reduction
Time frame: after 12-week treatment
Change from baseline in numeric rating scale (NRS)
Time frame: after 4, 8 and 12 week treatment
Change from baseline in immunologic blood marker (Total immunoglobulin E (IgE), Eosinophil counts)
Time frame: after 12-week treatment
Change from baseline n Children's Dermatology Life Quality Index (CDLQI) or Infants Dermatitis Quality of Life index (IDQoL)
Time frame: after 4, 8 and 12 week treatment
Change from baseline in Dermatology Family Impact (DFI)
Time frame: after 4, 8 and 12 week treatment
Quantity of emollients
Time frame: after 4, 8 and 12 week treatment
Proportion of participants using topical corticosteroids and quantity of topical corticosteroids
Time frame: after 4, 8 and 12 week treatment
Number of days with or without topical corticosteroids
Time frame: after 4, 8 and 12 week treatment
Drop-out rate using topical corticosteroids
Time frame: after 4, 8 and 12 week treatment
Incidence of adverse event (AE)'s
Time frame: From Baseline through Week 12 (entire study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kui Young Park principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHT-3201 in people with Dermatitis, Atopic, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Jung Kim (821087721492, mjkim90@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Scoring Atopic Dermatitis (SCORAD) total score (time frame: after 12-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.