NIPH Clinical Trials Search

A Study on the Effectiveness and Safety of Ultrasound Treatment for Skin Tightening

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Subjects with self-reported symptoms of skin sagging and concerns about skin quality associated with
Date of first enrollment	01/05/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Ultrasound-based treatment for skin tightening

Outcome(s)

Primary Outcome	Efficacy Evaluation by Investigator Assessment of changes from baseline to post-treatment using 2D and 3D images obtained with a skin imaging device (Global Aesthetic Improvement Scale [GAIS]) Evaluation of effectiveness based on a standardized grading scale for perioral wrinkles
Secondary Outcome	Changes from Pre-treatment to Post-treatment 1) Changes in skin physiological parameters 2) Changes in epidermal and dermal thickness and density assessed by ultrasound imaging 3) Histological evaluation based on skin biopsy specimens 4) Brightness analysis using a skin imaging system 5) Subject-reported outcomes (questionnaire-based assessment)

Key inclusion & exclusion criteria

Age minimum	>= 35age old
Age maximum	< 70age old
Gender	Both
Include criteria	1) Male or female subjects aged 35 to 70 years 2) Non-smokers 3) Subjects with symptoms of skin sagging associated with age-related changes 4) Subjects with self-reported concerns regarding skin quality associated with age-related changes 5) Subjects who are able to provide written informed consent voluntarily to participate in this study 6) Women of childbearing potential who are not postmenopausal must have been using a reliable method of contraception (e.g., hormonal contraceptives, intrauterine devices, surgical sterilization, or abstinence) for at least three months prior to enrollment and must continue to do so throughout the study period. 7) Participants must be able to comply with all study visit schedules specified in this study, including screening, treatment, and follow-up visits at 1 month, 3 months, and 6 months after treatment.
Exclude criteria	1) Facial conditions - Presence of inflammatory skin disease or skin infection affecting the face - Presence of implanted metal stents or implants - Participants who have received any intradermal or subcutaneous injection treatments to the skin within 6 months prior to enrollment are excluded. This includes, but is not limited to, hyaluronic acid fillers, botulinum toxin products, polynucleotide preparations, autologous blood-derived therapies (e.g., PRP), and lipolytic injections. - Participants who have undergone cosmetic device-based treatments within 12 months prior to enrollment are excluded. This includes, but is not limited to, laser devices, radiofrequency (RF) devices, and ultrasound-based devices. - Use of home-use facial devices intended to improve skin sagging within 1 month prior to enrollment - Presence of significant scar tissue 2) Underlying medical conditions - Diagnosis of diabetes mellitus or autoimmune disease 3) Medication use - Use of tretinoin or other vitamin A derivatives (including oral and topical forms) within 2 weeks prior to enrollment 4) Pregnancy and lactation - Women who are pregnant, may be pregnant, are less than 3 months postpartum, or are breastfeeding 5) Other - Subjects deemed unsuitable for participation in this study by the principal investigator or sub-investigator