UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009621 |
|---|---|
| Receipt number | R000011287 |
| Scientific Title | An exploratory research investigating the appropriate usage and clinical evaluation of compound Monoammonium glycyrrhizinate Glycine DL-Methionine tablet on mild alopecia areata |
| Date of disclosure of the study information | 2012/12/28 |
| Last modified on | 2013/11/26 18:53:26 |
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Basic information
Public title
An exploratory research investigating the appropriate usage and clinical evaluation of compound Monoammonium glycyrrhizinate Glycine DL-Methionine tablet on mild alopecia areata
Acronym
An exploratory research investigating the appropriate usage and clinical evaluation of compound Monoammmonium glycyrrhizinate Glycine DL-Methionine tablet on mild alopecia areata
Scientific Title
An exploratory research investigating the appropriate usage and clinical evaluation of compound Monoammonium glycyrrhizinate Glycine DL-Methionine tablet on mild alopecia areata
Scientific Title:Acronym
An exploratory research investigating the appropriate usage and clinical evaluation of compound Monoammmonium glycyrrhizinate Glycine DL-Methionine tablet on mild alopecia areata
Region
| Japan |
Condition
Condition
Mild alopecia areata
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory examination of the clinical evaluation and appropriate use of glycyrrhizin-containing tablets as a treatment for alopecia areata based on clinical evaluation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical efficacy after 12 weeks treatment (e.g., doctor's findings, determination of disease course, subject's impression, and photographs of observed lesions)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application of an appropriate amount of carpronium solution to the affected area twice daily (once in morning and in once evening) for 12 weeks.
Interventions/Control_2
In addition to application of an appropriate amount of carpronium solution to the affected area twice daily (once in morning and once in evening), administration of a total of 9 glycyrrhizin-containing tablets daily (three tablets three times a day after each meal).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients having less than five observed isolated hair loss areas, covering less than 25%
2) Male and female patients aged 20 years or older at time of informed consent
3) Patients who provide written consent of agreement to voluntarily participate in the clinical study
Key exclusion criteria
1)Patients who have advanced eczema and/or dermatitis of the scalp
2)Patients in whom three or more hairs are lost in hair pull test
3)Patients who have received oral steroid treatment, inhalation treatment, local steroid injection, or external steroid treatment for scalp within one month before the date of informed consent
4)Patients who have used medical products that claim promotion of hair growth, prevention of hair loss, or hair restoration action within one month before the date of informed consent
5)Patients with a history of allergic reaction to carpronium or glycyrrhizin
6)Patients diagnosed with malignant tumor
7)Patients with serious liver, renal, or cardiac disease
8)Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant during the study period
9)In addition, patients who are determined as ineligible by the study doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kubo |
Organization
Institute of Health Biosciences,
The University of Tokushima Graduate School
Division name
Pathologic Medicine for Cutaneo-motoric System,Department of Dermatology
Zip code
Address
3-8-15 Kuramoto-cho,Tokushima,Japan
TEL
088-633-7154
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Support center for alopecia areata research
Division name
Satt Co., Ltd. Customer Satisfaction Department
Zip code
Address
Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-5312-5026
Homepage URL
aa-study@sa-tt.co.jp
Sponsor or person
Institute
Institute of Health Biosciences
,The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan Inc.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 25 | Day |
Last modified on
| 2013 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011287
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