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KM110329 in Adult Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01692093
Recruitment Status : Unknown
Verified November 2013 by Seong-Gyu Ko, Kyunghee University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 25, 2012
Last Update Posted : November 14, 2013
Sponsor:
Collaborators:
St Mary's Hospital, London
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Kyung Hee University Hospital at Gangdong
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center

Tracking Information
First Submitted Date  ICMJE September 17, 2012
First Posted Date  ICMJE September 25, 2012
Last Update Posted Date November 14, 2013
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
SCORAD index [ Time Frame: 8 weeks ]
SCORing Atopic Dermatitis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01692093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
DLQI [ Time Frame: 8 weeks ]
The Dermatology Life Quality Index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 20, 2012)
  • TEWL [ Time Frame: 8 weeks ]
    Transepidermal Water Loss
  • hydration in the stratum corneum [ Time Frame: 8 weeks ]
    hydration in the stratum corneum
  • KiFDA-HM-AD [ Time Frame: 8 weeks ]
    Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE KM110329 in Adult Patients With Atopic Dermatitis
Official Title  ICMJE KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial
Brief Summary The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.
Detailed Description

A randomized, double blind, placebo-controlled, multicenter trial will be conducted at the Seoul St.Mary's Hospital, at Chung-ang University hospital, and at Kyung Hee University Hospital at Gangdong.

Participants fulfilling eligibility criteria will be selected. Enrolled participants will be randomly allocated to two parallel groups: the KM110329 and placebo arms.

Each participant will be examined for signs and symptoms of Atopic dermatitis before and after taking functional food.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Dietary Supplement: KM110329
    KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
  • Dietary Supplement: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: KM110329
    Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
    Intervention: Dietary Supplement: KM110329
  • Placebo Comparator: Control
    Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
    Intervention: Dietary Supplement: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 20, 2012)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01692093
Other Study ID Numbers  ICMJE CCRG_KM110329
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seong-Gyu Ko, Kyunghee University Medical Center
Study Sponsor  ICMJE Kyunghee University Medical Center
Collaborators  ICMJE
  • St Mary's Hospital, London
  • Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  • Kyung Hee University Hospital at Gangdong
Investigators  ICMJE
Study Director: SEONG GYU KO, M.D.(DKM) Kyunghee University
PRS Account Kyunghee University Medical Center
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP