UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056016 |
|---|---|
| Receipt number | R000064018 |
| Scientific Title | Tests on the use of skincare products during laser hair removal. |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/11/01 17:01:41 |
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Basic information
Public title
Tests on the use of skincare products during laser hair removal.
Acronym
Tests on the use of skincare products during laser hair removal.
Scientific Title
Tests on the use of skincare products during laser hair removal.
Scientific Title:Acronym
Tests on the use of skincare products during laser hair removal.
Region
| Japan |
Condition
Condition
Patients presenting for laser hair removal on the face (beard) and lower legs.
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Laser hair removal is now widely practised as a form of cosmetic medicine.Laserhairremovalisbased on the principle that the targeted hairs and the surrounding follicle are destroyed by the application of light with wavelengthsthatarehighlyabsorbent of the melanin in the target hair.The use of skincare products is often recommended due to the temporary sensitivityanddrynessoftheskinafter laser hair removal, but the usefulness of skincare products is not clear.This study will test the use of skincare productsafterlaserhairremovalto determine their safety and efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The study doctor will examine the subject at the beginning of the study, after oneweekandattheend of the study (after four weeks), assess and judge the following for each subject and enter them in the case card
Key secondary outcomes
At the end of the study (four weeks later) for each subject, the physician in charge of the study will assess the safety of the study on the basis of the occurrence of side effects in the following four levels and enter this assessment on a case card with commentsPhotography: In the case of facial (beard) hair removal, the face is photographed with a facial imaging device or digital camera at the start of the study, one week later and at the end of the study (four weeks later).In the case of hair loss on the anterior surface of the lower leg, photographs are taken with a digital camera.The condition of the pores is also photographed using a microscope as a magnified image.Skin measurements are taken at the start of the study, one week later and at the end of the study (four weeks later) at the examination.Both measuring instruments are not invasive to the skin as the measuring probes are in contact with the skin surface.Epidermal stratum corneum water content: stratum corneum water content is measured using a stratum corneum water content meter.Epidermal water transpiration: trans-epidermal water transpiration is measured using a trans-epidermal water transpiration meter.Sebum content (face only): measure sebum content using a sebum secretion meter.Skin colour: skin colour and L* (lightness), a* (redness), b* (yellowness), MI (melanin index) and EI (erythema index) are measured using a spectrophotometer.Stratum corneum assessment: a Sellotape is gently pressed on the face (forehead, cheeks and chin) or on the anterior aspect of the lower leg to collect the outermost layer of the stratum corneum.Fluorescence immunostaining, ELISA and enzyme assays are used to analyse skin bioactive substances related to inflammation, keratinisation and skin barrier function.Questionnaire survey: Questionnaires will be administered at the start of the study, after 1 week and at the end of the study (after 4 weeks).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Skin care guidance, use of skin care products
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects are patients who have visited the Takano Medical Clinic or Sawano Clinicforlaserhairremoval on the face (beard) or anterior lower leg, who are judged by the physician in charge of the study to have no problems withparticipation inthestudybased on skin findings and medical interview, and who areSubjects are patients who have visited the Takano Medical Clinic orSawano Clinic forlaserhairremoval on the face (beard) or anterior lower leg, who are judged by the physician in charge of the study to have no problems withparticipation inthestudybased on skin findings and medical interview, and who are(i) Adults aged 18 years or older (ii) Male subjects for facial (beard)hair removal,andgender-neutral subjects for leg hair removal (iii) Subjects who have been fully informed about the study, fully understand it and givetheir freeandvoluntarywritten consent to participate.In addition, there are no restrictions on treatment in cases where the subject has a diseaseother than askindisease (other diseases).
Key exclusion criteria
(i) Those with serious skin diseases.(ii) In principle, those who cannot be examinedafteroneweek and at the end of the study (after four weeks).(iii) Any other person who is judged by the study physician to be unsuitable to participate in the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | MIEKO |
| Middle name | |
| Last name | HATA |
Organization
Takano Medical Clinic
Division name
Department of Dermatology
Zip code
125-0062
Address
6-4-23 Aoto, Katsushika-ku, Tokyo
TEL
03-3601-2788
yumi_murakami@n1.noevir.co.jp
Public contact
Name of contact person
| 1st name | YUMI |
| Middle name | |
| Last name | MURAKAMI |
Organization
TOKIWA Pharmaceutical Co., Ltd.
Division name
NOV Academic Research
Zip code
1070062
Address
1-2-6 Minami-aoyama Minato-ku
TEL
08024879414
Homepage URL
yumi_murakami@n1.noevir.co.jp
Sponsor or person
Institute
Takano Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
Tokiwa Pharmaceutical Co. will provide appropriate skincare products. In addition, TokiwaPharmaceutical Industries, Ltd. will provide an honorarium at the end of the study.
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
Yoyogi Mental Clinic Research Ethics Committee
Address
4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6455-4173
cns_jimu@triad-j.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
| 2024 | Year | 11 | 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
23
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064018
