Набор по приглашению NCT06726122

Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment

Без фазы С лечением Skin Laxity Wrinkle Skin Condition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Profound Matrix.
Кому может быть актуально: Состояния в реестре: Skin Laxity, Wrinkle, Skin Condition. Базовые параметры: 18 лет — 84 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment for Facial, Submental and Neck Laxity

Обзор

This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.

Подробное описание

Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion

Вмешательства

Устройство Profound Matrix
Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks).

Первичные конечные точки

Evaluation of change in facial, submentum, and neck laxity [Срок оценки: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.]

Критерии участия

Критерии включения

Healthy female and male subjects between 18 to 84 years of age with Fitzpatrick Skin Type I - VI.
Willing to receive Profound Matrix treatments with Matrix Pro applicator
Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
Willing to provide signed, informed consent to participate in the study
Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials (Subject identity will be masked).

Критерии исключения

Any of the following will exclude the subject from the study:

Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
Superficial metal or other implants in the treatment area, except superficial dental implants, unless the implants can be removed or covered with rolled gauze during treatment
Skin cancer in the treatment area or history of melanoma
History of current cancer and/or subject has undergone chemotherapy within the last 12 months
Severe concurrent conditions, such as cardiac disorders
Impaired immune system or use of immunosuppressive medications, except for topical products and inhaler medications per investigator discretion
Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
Poorly controlled endocrine disorders such as poorly controlled diabetes
Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
History of collagen vascular disease or vasculitic disorders
Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g., lidocaine)
History of systemic corticosteroid therapy in past six months
Tattoos or permanent makeup in the intended treatment area
Excessively tanned skin
Facelift in the last 12 months
Aesthetics treatments/procedures (e.g., facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area
Neuromodulator injections (e.g., Botox®), collagen, non-permanent dermal filler, fat injections or other methods of augmentation with injected biomaterial in the intended treatment area within the last 3 months
Permanent synthetic fillers (e.g., silicone) in the intended treatment area
Absorbable facial threads within the last 12 months or non-absorbable facial threads within the intended treatment area
In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for study participation