Tokyo, April 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061350) titled 'Effects of Using Home-Use Facial Devices on Skin Condition and Body Contour' on April 23.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Japan Clinical Trial Association
Condition:
Condition - Healthy adult Female
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The Effects of Using Home-Use Beauty Devices on Skin Condition and Body Contours
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use the beauty device and a specific gel on one side of the face and body for 4 weeks (however, apply to the entire waist and hips).
Interventions/Control_2 - Do not apply the test product to the other side of the face and body.
Eligibility:
Age-lower limit - 35
years-old
Gender - Female
Key inclusion criteria - Subjects who are aware of loss of facial firmness, dark spots, wrinkles, visible pores, or sagging of the body
BMI of 20 or higher but less than 25.0
Subjects who can use the test device on one side of their face and body for just under 30 minutes every day during the trial period
Subjects who can commit to not changing their lifestyle habits (diet, exercise, sleep, and skincare routines)
Key exclusion criteria - Subjects with cosmetic allergies, atopic dermatitis, or skin prone to irritation
Subjects who are sensitive to the tingling sensation characteristic of facial beauty devices
Subjects with a history of inflammation, eczema, excessive dryness, or contact dermatitis at the treatment site
Subjects who have undergone procedures such as laser treatment, thread lifts, Botox, hyaluronic acid injections, or liposuction at the treatment site within the past six months, or who plan to undergo such procedures during the trial period
Subjects with metal implants (such as bolts or pacemakers) or those with severe metal allergies
Pregnant or breastfeeding individuals
Subjects currently undergoing hormone replacement therapy
Subjects taking supplements or medications that may affect the efficacy of the test product
Subjects with eyelash extensions or permanent makeup (such as eyeliner) around the eyes
Subjects who have participated in a human clinical trial within the past month, or who plan to do so during the trial period
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 25 Day
Date of IRB - 2026 Year 03 Month 26 Day
Anticipated trial start date - 2026 Year 04 Month 20 Day
Last follow-up date - 2026 Year 05 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070194
Disclaimer: Curated by HT Syndication.