■ Study Purpose
The purpose of this study is to evaluate the effects of Shurink Universe (Ultraformer MPT) on submental fat reduction, skin elasticity improvement, and skin-related adverse reactions.
■ Recruitment Criteria
[Inclusion Criteria]
1) Multiracial individuals with submental fat and sagging in the facial area (CR-SMFRS score ≥ 1)
2) Healthy volunteers without significant systemic diseases
3) Individuals who are available for follow-up observations throughout the study period
4) Individuals who have been fully informed by the investigator about the purpose and details of the study and who voluntarily signed the informed consent form to participate in the clinical study
*Individuals with submental sagging similar to the images above
■ Recruitment Criteria
[Exclusion Criteria]
1) Individuals who have received treatment with the same or similar efficacy device on the study area within 1 month prior to study initiation
2) Individuals with severe acute renal or cardiac diseases, or other chronic diseases that may affect the study results (e.g., hypertension, diabetes mellitus) within the past 6 months
3) Individuals who are pregnant, breastfeeding, or planning to become pregnant within 6 months
4) Individuals with skin disorders on the study area (including severe inflammation, eczema, psoriasis, skin cancer, etc.), skin allergies, sensitive skin, or hypersensitive skin
5) Individuals who have taken the following medications within the past 1 month:
6) Steroids, cytotoxic agents, vasodilators, antihypertensive agents, antiepileptic agents, beta-blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, or ketoconazole
7) Individuals who are continuously taking contraceptives, antihistamines, or anti-inflammatory drugs
8) Individuals who are employees of this clinical research institution
9) Any other individuals deemed unsuitable for participation in this study by the Principal Investigator
■ Evaluation Items
1) Expert Visual Assessment
2) Subject Satisfaction Assessment
3) Instrumental Measurements
(1) Facial Photography
(2) Evaluation of Chin/Submental Fat Volume and Angle
(3) Skin Elasticity Assessment
4) Pain Questionnaire Assessment
