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
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Dietary Supplement: KM110329 Dietary Supplement: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||September 2014|
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
KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
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.
Dietary Supplement: Placebo
- SCORAD index [ Time Frame: 8 weeks ]SCORing Atopic Dermatitis
- DLQI [ Time Frame: 8 weeks ]The Dermatology Life Quality Index
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692093
|Korea, Republic of|
|Kyung Hee University||Recruiting|
|Seoul, Korea, Republic of, 130-701|
|Contact: CHUNHOO CHEON, M.D.(DKM) 82-2-961-9278 email@example.com|
|Study Director:||SEONG GYU KO, M.D.(DKM)||Kyunghee University|