UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050130 |
|---|---|
| Receipt number | R000057095 |
| Scientific Title | Assessment of the effectiveness of 2GA16-containing formulation for atopic dermatitis |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/11/29 12:19:31 |
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Basic information
Public title
Assessment of the safety and efficacy of 2GA16-containing cream in patients with atopic dermatitis
Acronym
Assessment of the safety and efficacy of 2GA16-containing cream in patients with atopic dermatitis
Scientific Title
Assessment of the effectiveness of 2GA16-containing formulation for atopic dermatitis
Scientific Title:Acronym
Assessment of the effectiveness of 2GA16-containing formulation for atopic dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of 2GA16-containing moisturizer in the standard treatment of atopic dermatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation of skin findings and confirmation of adverse events by a dermatologist
Key secondary outcomes
Transepidermal water loss
Stratum corneum water content
Stratum corneum analysis
Image analysis
Patient questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Left-right comparison study (face)
A group
Left side: test cream
Right side: 0.3% heparinoid-containing cream
Each creams are applied twice daily for 11 weeks.
Interventions/Control_2
Left-right comparison study (face)
B group
Left side: 0.3% heparinoid-containing cream
Right side: test cream
Each creams are applied twice daily for 11 weeks.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1) Japanese females between 20 and 59 years old with atopic dermatitis
2) Subjects with mild atopic dermatitis symptoms on the left and right sides of the face
3) Subjects who are currently undergoing treatment with topical agents, or who have had treatment after becoming an adult
Key exclusion criteria
1) Those with atopic dermatitis who do not meet the selection criteria
2) Those who are taking systemic administration (oral or intravenous injection) of steroids, JAK inhibitors, biologics or immunosuppressant
3) Those who regularly use anti-inflammatory medications or antiallergic medications
4) Those who are undergoing PUVA therapy
5) Those who have undergone aesthetic medicine or special skin care treatments (peeling, hair removal treatment, etc.) within 4 weeks prior to the 0w test date, or those who plan to receive them during the test period.
6) Subjects who have been exposed to ultraviolet rays beyond their daily lives, such as working outdoors for long periods of time, exercising, swimming at the beach, or leisure activities within 4 weeks prior to the 0w test date, and those who have such a plan during the exam period
7) Those who work night shift or day and night shift
8) Those who are receiving treatment other than atopic dermatitis at a medical institution at the time of obtaining consent
9) Those who are a history of alcohol or drug dependence
10) Those who are likely to develop allergies to cosmetics and food (including those who have experienced skin abnormalities such as rashes due to cosmetics within the past year)
11) Those who have other serious underlying diseases
12) Those who are currently participating in other clinical trials, or those who have participated in clinical trials within the past 2 months
13) Women who are pregnant, planning to become pregnant, or breastfeeding
14) Those who have difficulty coming to the hospital on the specified date
15) In addition, those who are judged to be inappropriate for participation in this study by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Nakaoji |
Organization
Pias Corporation
Division name
Central R&D Laboratory
Zip code
6512241
Address
1-3-1, Murotani, Nishi-ku, Kobe, Hyogo, Japan
TEL
078-992-6591
knakaoji@pias.co.jp
Public contact
Name of contact person
| 1st name | Shunya |
| Middle name | |
| Last name | Sahara |
Organization
Pias Corporation
Division name
Central R&D Laboratory
Zip code
6512241
Address
1-3-1, Murotani, Nishi-ku, Kobe, Hyogo, Japan
TEL
078-992-6591
Homepage URL
ssahara@pias.co.jp
Sponsor or person
Institute
Pias Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Shibukawa Central Hospital, Medical Corporation Kikuei-kai
Address
508-1, Ishihara, Shibukawa, Gunma, Japan
Tel
0279-26-9102
aoyama@oms-laboratory.co.jp
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
| 2023 | Year | 02 | Month | 01 | 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
24
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
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057095
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| Registered date | File name |
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