Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation

Обзор

The purpose of this study is to evaluate whether microneedling RF subcutaneous fat pad thickness in the temple, submental, and cheek regions, to determine whether the addition of topical PLLA after microneedling RF alters or preserves subcutaneous fat pad thickness and to assess patient satisfaction and perceived outcomes following microneedling RF ± PLLA treatment.

Вмешательства

• Устройство microneedling RF treatment
  Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart
• Устройство PLLA
  Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment
• Препарат Sterile Water as control
  Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment

Первичные конечные точки

• Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging [Срок оценки: Baseline, 6 months]

Вторичные конечные точки (6)

• Difference in fat pad thickness between the RF+PLLA side and RF-only side as assessed by ultrasound imaging [Срок оценки: 6 months]
• Patient reported overall improvement in appearance as assessed by the Global Aesthetic Scale [Срок оценки: 6 months]
• Change in satisfaction with forehead as assessed by the patient questionnaire [Срок оценки: Baseline, 6 months]
• Change in satisfaction with cheek as assessed by the patient questionnaire [Срок оценки: Baseline, 6 months]
• Change in satisfaction with submental as assessed by the patient questionnaire [Срок оценки: Baseline, 6 months]
• Change in overall social confidence as assessed by the patient questionnaire [Срок оценки: Baseline, 6 months]

Критерии участия

Критерии включения

• Seeking facial rejuvenation for cosmetic concerns
• Able and willing to provide informed consent
• Willing to comply with study procedures and follow-up visits

Критерии исключения

• Prior filler injection or energy-based device treatment to the face within the past 6 months
• Previous facial surgeries
• Pregnant or breastfeeding
• Active infection, dermatitis, or open lesions in the treatment area
• History of keloids or abnormal scarring
• Known allergy to poly-L-lactic acid (PLLA)- Current participation in another clinical trial involving facial aesthetic treatments
• Presence of pre-cancerous or cancerous lesions in the treatment area
• Current or planned use of glucagon-like peptide-1 receptor agonists (e.g., Ozempic, semaglutide) during the study period. Subjects on these medications will be excluded due to potential effects on facial fat and overall weight.
• HIV+ patients
• Patients on HIV medications- Patients that have eczema and rosacea

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

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT07261527 · HSC-MS-25-0585

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗