Tokyo, Sept. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062840) titled 'A study of adherence to skincare using medicated cosmetics and quality of life in patients with cancer' on Sept. 7.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Hyogo Cancer Center
Condition:
Condition - Skin concerns such as xerosis, hyperpigmentation, and wrinkles in patients with cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 80
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071936
Disclaimer: Curated by HT Syndication.