NCT01692093

Brief Summary

The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1.7 years

First QC Date

September 17, 2012

Last Update Submit

November 12, 2013

Conditions

Atopic Dermatitis

Keywords

SCORADAtopic dermatitsSkin health

Outcome Measures

Primary Outcomes (1)

  • SCORAD index

    SCORing Atopic Dermatitis

    8 weeks

Secondary Outcomes (1)

  • DLQI

    8 weeks

Other Outcomes (3)

  • TEWL

    8 weeks

  • hydration in the stratum corneum

    8 weeks

  • KiFDA-HM-AD

    8 weeks

Study Arms (2)

KM110329

EXPERIMENTAL

Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.

Dietary Supplement: KM110329

Control

PLACEBO COMPARATOR

Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.

Dietary Supplement: Placebo

Interventions

KM110329DIETARY_SUPPLEMENT

KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health

KM110329
PlaceboDIETARY_SUPPLEMENT

Placebo

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ages 18 to 65 years
  • Individuals who diagnosed Atopic dermatitis according to the criteria of Hanifin and Rajka
  • Individuals who mild to moderate atopic dermatitis (objective SCORAD≤40)
  • Written informed consent for participation in the trial

You may not qualify if:

  • Severe skin disease other than Atopic dermatitis
  • Secondary infection with bacteria, fungi, and virus
  • Uncontrolled hypertension (SBP \> 145 mmHg or DBP \> 95 mmHg)
  • Severe liver disability (2.5-fold the normal high range value for ALT, AST)
  • Severe renal disability (sCr \> 2.0mg/dl)
  • Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age who do not agree to proper contraception
  • Use of oral steroids, oral antibiotic or other immunosuppressants within the past 4 weeks
  • Treated by systemic photochemotherapy within past 4 weeks
  • History of drug abuse
  • Hypersensitivity to Rubi Fructus, Houttuyniae Herba, Rehmanniae Radix, Betulae Platyphyllae Cortex
  • Use of other investigational products within the past two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University

Seoul, 130-701, South Korea

RECRUITING

Related Publications (1)

  • Cheon C, Park S, Park JS, Oh SM, Jang S, Go HY, Jang BH, Shin YC, Ko SG. KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial--study protocol. BMC Complement Altern Med. 2013 Nov 27;13:335. doi: 10.1186/1472-6882-13-335.

    PMID: 24279519DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • SEONG GYU KO, M.D.(DKM)

    Kyunghee University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 25, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

KR(1)