UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060113 |
|---|---|
| Receipt number | R000068742 |
| Scientific Title | Observational Study after Aesthetic Treatment (Laser/Light therapy) |
| Date of disclosure of the study information | 2025/12/19 |
| Last modified on | 2025/12/18 10:06:15 |
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Basic information
Public title
Observational Study After an Aesthetic treatment
Acronym
Observational Study After an Aesthetic treatment
Scientific Title
Observational Study after Aesthetic Treatment (Laser/Light therapy)
Scientific Title:Acronym
Observational Study After an Aesthetic treatment
Region
| Japan |
Condition
Condition
Acquired melanin pigmentation/Benign tumors
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observation after laser (CO2, Q-switched) and IPL treatments on benign small tumors and acquired pigmentation: A longitudinal study of the wound healing process
Basic objectives2
Others
Basic objectives -Others
To observe the healing process following treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Development of a Photographic Scale for Assessing the Healing Process: Longitudinal Observation of Treatment Sites
Key secondary outcomes
ANTERA measurement (melanin, hemoglobin, L* value, a* value, b* value, concavity, scar area)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged between 20 and 59 years old.
(2) Those who wish to undergo or are planning to undergo aesthetic treatment.
(3) Patients with benign small tumors (seborrheic keratosis, soft fibroma, etc.) or acquired hyperpigmentation (senile hyperpigmentation, spermatorrhea, etc.) as determined by the principal
investigator.
Key exclusion criteria
(1) Those who suffer from chronic inflammatory skin diseases (atopic dermatitis, psoriasis, etc.).
(2) Those who have extreme sunburn on the face.
(3) Those who have a tendency to develop keloids.
(4) Those who are determined by the principal investigator to require treatment for a disease.
(5) Women who are breastfeeding, pregnant, or potentially pregnant.
(6) Those who are otherwise determined to be unsuitable by the Principal Investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Hasegawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Dermatology and Allergology,
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo Ward, Tokyo
TEL
+81-3-3813-3111
t-hase@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Shimotoyodome |
Organization
Kao Corporation
Division name
Human Healthcare Product Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo,
TEL
+81-3-5630-9064
Homepage URL
shimotoyodome.yoshie@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131- 8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2025 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
22
Results
After the treatment, the wound healing process was observed, and a photo scale for the wound healing process was created.
Results date posted
| 2025 | Year | 12 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adults men and women
Participant flow
Screening->enrollment->intervention->follow-up. Obtained 30 cases from 22 participants; 0 withdrawals.
Adverse events
None reported
Outcome measures
-Photographic evaluation (crusting score, inflammation score, pigmentation, swelling score, epithelialization score)
-Instrumentation (melanin content, hemoglobin content, indices of skin concavity, etc.)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 22 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 17 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 29 | Day |
Other
Other related information
Temporal changes after cosmetic procedures and their relationship with skin characteristics
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068742
