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A 12 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of SCE on atopic dermatitis in children

A 12 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of SCE on atopic dermatitis in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002233
Enrollment
80
Registered
2017-02-21
Start date
2016-11-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : take a 20g stick of active medication(containing 80mg of Smilacis Chinae Rhizoma extract in a stick) or Placebo 1 stick though randomaization once daily for 12 weeks.

Sponsors

Novarex
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)subject who signs Informed Consent Form with a legal representative who signs the informed consent form before participating in the study 2)subject aged between 3 years and 12 years with atopic dermatitis 3)subject with intermittent or continuous atopic dermatits symptom over 6 months 4)subject with SCORing of Atopic Dermatitis index between 25 and 50

Exclusion criteria

Exclusion criteria: 1)subject with other systemic illnesses or dermatits history except Atopic Dermatitis 2)subject administrating immunosuppressant,antobiotics,corticosteroid, antihistaminic within 4 weeks 3)subject who has taken medicines,chinese medicine, health functional foods within 4 weeks for improvement of atopic dermatitis

Design outcomes

Primary

MeasureTime frame
SCORing of Atopic Dermatitis score

Secondary

MeasureTime frame
SCORing of Atopic Dermatitis objective score;SCORing of Atopic Dermatitis subjectiv score;Investigator’s Global Assessment

Countries

Korea, Republic of

Contacts

Public ContactSo Min

Chung-Ang Univerisity Hospital

tonhuk28@naver.com+82-2-823-1049

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026