UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062840 |
|---|---|
| Receipt number | R000071936 |
| Scientific Title | Adherence to skincare using medicated cosmetics and changes in skin-related quality of life in patients with cancer: a multicenter nonrandomized comparative study |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/07 18:04:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of adherence to skincare using medicated cosmetics and quality of life in patients with cancer
Acronym
Cancer Skincare Study
Scientific Title
Adherence to skincare using medicated cosmetics and changes in skin-related quality of life in patients with cancer: a multicenter nonrandomized comparative study
Scientific Title:Acronym
Cancer Skincare Study
Region
| Japan |
Condition
Condition
Skin concerns such as xerosis, hyperpigmentation, and wrinkles in patients with cancer
Classification by specialty
| Dermatology | Plastic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate 12-week adherence to a skincare regimen using medicated cosmetic products in patients with cancer compared with noncancer controls, and to assess changes in skin findings and quality of life during the intervention.
Basic objectives2
Others
Basic objectives -Others
Evaluation of adherence to the skincare regimen
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of participants who continue use of the study skincare products through 12 weeks after initiation (12-week continuation rate), compared between the cancer group and the noncancer control group.
Key secondary outcomes
1,Changes in physician-assessed skin findings (scaling, xerosis, erythema, and hyperpigmentation) from baseline to weeks 4 and 12.
2,Changes in skin-related quality of life assessed using Skindex-16 from baseline to weeks 4 and 12.
3,Changes in psychological status assessed using the Hospital Anxiety and Depression Scale (HADS) from baseline to weeks 4 and 12.
4,Adverse events during use of the study products.
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
| Other |
Interventions/Control_1
Participants use Collage Repair Lotion R and Collage Repair Bright Essence DR for 12 weeks. In principle, participants replace the lotion and serum used before enrollment with the study products and apply them twice daily, in the morning and evening, at home. Other products used before study entry, including makeup remover, facial cleanser, sunscreen, and emulsion or moisturizer, may be continued. The same intervention is provided to participants with cancer and noncancer controls.
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
1,Participants aged 18 years or older at the time of informed consent.
2,Cancer group: outpatients with cancer who have skin concerns such as xerosis, hyperpigmentation, or wrinkles that do not require dermatologic treatment. Both patients with active cancer and those who have completed cancer treatment are eligible.
3,Noncancer control group: healthy individuals who do not meet the cancer-specific criterion described above.
4,Participants who receive an explanation of the study and provide informed consent.
Key exclusion criteria
1,Participants with severe skin disease.
2,Participants with a history of contact dermatitis or similar skin reactions caused by a study product or a product containing similar ingredients.
3,Participants who are expected to have difficulty attending the end-of-study assessment.
4,Participants considered unsuitable for study participation by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Misato |
| Middle name | |
| Last name | Ueda |
Organization
Hyogo Cancer Center
Division name
Department of Plastic Surgery
Zip code
673-8558
Address
13-70 Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
TEL
078-929-1151
sakuramochi0v0@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Kumanishi |
Organization
Hyogo Cancer Center
Division name
Department of Plastic Surgery
Zip code
673-8558
Address
13-70 Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
TEL
078-929-1151
Homepage URL
kumaray109@gmail.com
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Mochida Healthcare Co., Ltd.
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
Ethics Review Committee of Hyogo Cancer Center
Address
13-70 Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
Tel
078-929-1151
hcc-rinri@hyogo-cc.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
兵庫県立がんセンター（兵庫県）
神戸大学医学部附属病院（兵庫県）
和歌山県立医科大学（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 07 | 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
68
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
Data may be shared upon reasonable request, subject to applicable ethical and institutional restrictions.
IPD sharing Plan description
De-identified data supporting the findings of this study may be made available from the corresponding author upon reasonable request, subject to applicable ethical and institutional restrictions.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was conducted as a prospective interventional study but was retrospectively registered in UMIN-CTR after completion of the study. The target sample size was 80 participants (40 in the cancer group and 40 in the control group), and enrollment was closed after 68 participants had been enrolled (34 in the cancer group and 34 in the control group).
Management information
Registered date
| 2026 | Year | 09 | Month | 07 | Day |
Last modified on
| 2026 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071936
