KM110329 in Adult Patients With Atopic Dermatitis
|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
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 firstname.lastname@example.org|
|Study Director:||SEONG GYU KO, M.D.(DKM)||Kyunghee University|