Clinical trial for the evaluation of the efficacy and safety of KACC91563 on atopic dermatitis in children

A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of KACC91563 on atopic dermatitis in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003822

Enrollment

100

Registered

2019-04-19

Start date

2018-01-17

Completion date

Unknown

Last updated

2020-08-18

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 : Subjects will be randomized to the test group or control group. Subjects will orally self-adminster test food or placebo twice, 1 dose per day for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The subjects and their parents(or legal representatives), who has agreed to participate in this study and voluntarily signed the Informed consent form 2) The subjects, who aged between 1 and 12 years 3) The subjects, who has intermittent or continuous atopic dermatitis more than 6 months

Exclusion criteria

Exclusion criteria: 1) The subjects with severe skin and systemic diseases other than atopic dermatitis 2) The subjects, who has administered systemic antibiotics, corticosteroids, antihistamines and immunosuppressants for atopic dermatitis within 1 week before the human application test. 3) The subjects, who is deemed unfit for this human application test by the Investigator

Design outcomes

Primary

Measure	Time frame
SCORAD(SCORing of Atopic Dermatitis)	—

Secondary

Measure	Time frame
IGA(Investigator's global assessment)	—

Countries

Korea, Republic of

Contacts

Public ContactJung Im

Seoul National University Bundang Hospital

Outcome results