Atopic DermatitisPhase 2NCT01692093
KM110329 in Adult Patients With Atopic Dermatitis
A Phase 2 study testing KM110329 in people with Atopic Dermatitis, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- KM110329
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University
Seoul, 130-701
CHUNHOO CHEON, M.D.(DKM), 82-2-961-9278, pm.thehoo@gmail.com
About this study
Official title: KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial
The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- KM110329, Placebo
- Keywords
- SCORAD, Atopic dermatits, Skin health
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KM110329Dietary supplement
KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| KM110329 | Experimental | Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD index
SCORing Atopic Dermatitis
Measured: 8 weeks
Secondary outcomes (1)
DLQI
The Dermatology Life Quality Index
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- St Mary's Hospital, London, Chung-Ang University Hospital, Kyung Hee University Hospital at Gangdong
- Responsible party
- Principal investigator, Seong-Gyu Ko, Kyunghee University Medical Center
- Investigators
- SEONG GYU KO, M.D.(DKM), Study director, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692093
- Sponsor's protocol ID
- CCRG_KM110329
- Status last verified
- Nov 2013
- First submitted
- 17 Sep 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24279519
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial
- ClinicalTrials.gov ID
- NCT01692093
- Acronym / sponsor ID
- CCRG_KM110329
- Conditions
- Atopic Dermatitis
- Keywords
- SCORAD, Atopic dermatits, Skin health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- St Mary's Hospital, London, Chung-Ang University Hospital, Kyung Hee University Hospital at Gangdong
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KM110329 | Experimental | Dietary Supplement: KM110329Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals. |
| Control | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KM110329KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health | Dietary supplement | KM110329 |
| PlaceboPlacebo | Dietary supplement | Control |
Primary outcome
SCORAD index
Time frame: 8 weeks
SCORing Atopic Dermatitis
1 secondary outcome
DLQI
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Derived from this study: PubMed 24279519Cheon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEONG GYU KO, M.D.(DKM) study director
Kyunghee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KM110329 in people with Atopic Dermatitis, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD index (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.