UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063277 |
|---|---|
| Receipt number | R000072432 |
| Scientific Title | Test on the Application of Aza-Oxohypoxanthine (AOH) Formulation Following SKINJET Treatment. |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/10/14 17:46:56 |
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Basic information
Public title
Test on the Application of Aza-Oxohypoxanthine (AOH)
Formulation Following SKINJET Treatment.
Acronym
Test on the Application of Aza-Oxohypoxanthine (AOH)
Formulation Following SKINJET Treatment.
Scientific Title
Test on the Application of Aza-Oxohypoxanthine (AOH)
Formulation Following SKINJET Treatment.
Scientific Title:Acronym
Test on the Application of Aza-Oxohypoxanthine (AOH)
Formulation Following SKINJET Treatment.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of AOH contained formulation on skin condition as post-treatment care following SKINJET treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Image Analysis
Transepidermal water loss
Key secondary outcomes
Viscoelasticity
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
SKINJET treatment is performed three times at two-week intervals.
AOH formulation is applied daily for six weeks.
Interventions/Control_2
SKINJET treatment is performed three times at two-week intervals.
Apply the regular skincare product (which does not contain AOH) daily for six 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 years or older, of either sex, who understand the details of the study and provide informed consent to participate.
Individuals who are willing to use only the designated cosmetic products during the study period.
Individuals whom the principal investigator deems eligible to participate in the study.
Key exclusion criteria
Individuals who are pregnant or breastfeeding.
Individuals who have previously undergone treatment involving metal plates, metal threads, or similar devices.
Individuals with a metal allergy or a tendency to develop keloids.
Individuals who currently have an implanted medical device, such as a pacemaker.
Individuals who have undergone dental treatment involving
implants, bridges, or similar devices.
Individuals with allergies to medications, such as local
anesthetics.
Individuals who are currently taking blood-thinning
medications.
Individuals with a history of epilepsy, diabetes mellitus (including diabetic
complications), malignant skin tumors, or autoimmune diseases.
Individuals who currently have symptoms of dermatitis or herpes simplex.
Individuals who have undergone aesthetic medical treatment on the face within one month prior to the start of the study.
Individuals who are currently participating in another
clinical trial, have
participated in another clinical trial within the past three months or are likely to
participate in another clinical trial during the study period.
Individuals whom the principal investigator otherwise
considers unsuitable for
participation in the study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Siori |
| Middle name | |
| Last name | Tazawa |
Organization
ST Skin Clinic Aoyama
Division name
Director
Zip code
107-0061
Address
2F, Sister Building, 2-9-14 Kita-Aoyama, Minato-ku, Tokyo 107-0061, Japan
TEL
080-7993-7272
stskincl@gmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Shimmyo |
Organization
Mitsubishi Corporation Life Sciences Limited
Division name
Development Group, Cosmetic Division
Zip code
100-6605
Address
5F, GranTokyo South Tower, 1-9-2 Marunouchi, chiyoda-ku, Tokyo 100-6605 Japan
TEL
03-6386-9355
Homepage URL
takahiro.shimmyo@mcls-ltd.com
Sponsor or person
Institute
Mitsubishi Corporation Life Sciences Limited
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
C&C Co., Ltd. Ethics Review Committee
Address
3F, Towa Higashi-Gotanda Building, 1-7-6 Higashi-Gotanda, Shinagawa-ku, Tokyo
Tel
03-6431-8761
nanbu@candc.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
STスキンクリニック青山(東京都)／ST Skin Clinic Aoyama
東京都立産業技術センター(東京都)／Tokyo Metropolitan Industrial Technology Research Institute
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072432
