Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device

Официальное название

Safety and Efficacy Assessment for the Temporary Facial(Both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Single Center, Compared, Randomized, Evaluator-Blinded, Superiority, Pivotal Clinical Trial

Обзор

The purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device.

Подробное описание

This is a prospective, single-center, comparative, randomized, evaluator-blinded, superiority, confirmatory clinical trial designed to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of an investigational medical device using radiofrequency current when applied to the face (both cheeks), compared with a control device.

Вмешательства

• Устройство Test arm
  Participants receive treatment with the investigational device VOLNEWMER applied to both cheeks.
• Устройство Control arm
  Participants receive treatment using the device in training mode that does not deliver radiofrequency energy.

Первичные конечные точки

• Change in Cutometer R7 values [Срок оценки: 12 weeks]

Вторичные конечные точки (4)

• Change in Cutometer R7 values [Срок оценки: 8 weeks]
• Percentage change from baseline in Cutometer R7 value [Срок оценки: week 8 and week 12]
• Global Aesthetic Improvement Scale (GAIS) [Срок оценки: 4 weeks, 8 weeks, and 12 weeks]
• Global Aesthetic Improvement Scale(GAIS) assessment [Срок оценки: 4, 8, and 12 weeks]

Критерии участия

Критерии включения

• Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent.
• Participants whose average Cutometer R7 value for both checks is ≤0.6.
• Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy.
• Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period.
• Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study
• Participants who have adequately understood the objectives and procedures of the clinical trial, voluntarily consent in writing to participate, and are able to complete the study as required.

Критерии исключения

• Participants who have any medical or dermatologic condition at the investigational medical device application area that may influence the conduct or results of the study.
• Participants who have scars or open lesions at the investigational medical device application area that may influence the conduct or results of the study.
• Participants who have metal stents or implants at the investigational medical device application area.
• Participants with severe solar elastosis.
• Participants judged by the investigator to have excessive facial subcutaneous fat requiring surgical intervention.
• Participants with a history of anaphylaxis or severe complex allergic reactions.
• Participants with a history of or predisposition to hypertrophic scars or keloid formation.
• Participants with a history of adverse reactions to EMLA cream or local anesthetics (However, this criterion does not apply to participants who will not use anesthetics such as EMLA cream).
• Participants who have clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system that are not controlled by medication, or who have a history of or are currently receiving treatment for psychiatric disorders that may significantly affect this study.
• Participants with active herpes virus infection or autoimmune disease.
• Participants currently diagnosed with diabetes mellitus or epilepsy.
• Participants taking more than 100 mg of aspirin or aspirin-containing medication per day.
• Participants with bleeding disorders or blood coagulation-related diseases, such as thrombosis.
• Participants who have received Botox or filler injections at the investigational medical device application area\* within 24 weeks prior to screening (\*Investigational medical device application area: For participants undergoing facial (both cheeks) treatment - Mid-face (eyes to upper lip), Lower-face (lower lip to chin)) (However, if Botox or fillers were injected into the face but not within the application area, at least 12 weeks must have elapsed since the procedure).
• Participants who have undergone laser or light therapy at the investigational medical device application area within 24 weeks prior to screening.
• Participants who have undergone surgical or non-surgical treatments, such as deep chemical peels or liposuction, at the investigational medical device application area within 24 weeks prior to screening.
• Participants who have used topical agents (steroids, retinoids; limited to medicinal products, excluding cosmetics) at the investigational medical device application area within 4 weeks prior to screening, or who plan to continue use during the study.
• Participants who have smoked 100 or more cigarettes in their lifetime (However, those who have abstained from smoking for 24 weeks prior to screening are eligible for enrollment).
• Participants who are currently participating in another interventional clinical trial within 4 weeks prior to screening, or who plan to participate in another interventional clinical trial during this study.
• Pregnant or lactating women.
• Participants who are otherwise deemed unsuitable for participation in this study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Classys Inc — Seoul

Публикации

• el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045. PMID 21315951

Идентификаторы

NCT: NCT07471399 · VM-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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