A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles in the Cheek Area

Обзор

The primary objective of the study is to evaluate the safety of GP0122 and GP0124 for the correction of lines and wrinkles in the cheek area.

Вмешательства

• Устройство GP0122
  Injectable gel.
• Устройство GP0124
  Injectable gel.

Первичные конечные точки

• Number of Participants With all Adverse Events (AEs) [Срок оценки: From Day 1 up to last visit (Up to 12 months)]
• Number of Participants With Post-Treatment Responses as Assessed Using Subject Diary Data [Срок оценки: From Day 1 up to Day 28]
• Participant's Pain Assessment Using Numeric Pain Scale (NPS) Immediately Post Treatment and 30 Minutes Post Treatment [Срок оценки: Immediately and 30 minutes after each treatment]

Вторичные конечные точки (2)

• Responder Rates Based on the Treating Investigator's Live Assessment of the GCWS at Rest at Months 3, 6, 9 and 12 [Срок оценки: At Months 3, 6, 9 and 12]
• Responder Rates Based on the Treating Investigator's Live Assessment of the CSQS-CL at Rest at Months 3, 6, 9 and 12 [Срок оценки: At Months 3, 6, 9 and 12]

Критерии участия

Inclusion Criteria: Adult males or non-pregnant, non-breastfeeding adult females.

• Participants with a GCWS At Rest score of Moderate or Severe on EACH side of the face, or Participants with a CSQS-CL score of Moderate, Severe, or Very severe on EACH side of the face.
• Intent to undergo treatment for correction of lines and wrinkles in the cheek region.
• Willing to abstain from any other facial plastic, surgical or cosmetic procedures in the cheek area for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).

Inclusion criteria 4-5 apply only to female participants of childbearing potential:

• Agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at screening, baseline and prior to receiving any study treatment.
• Negative UPT at the screening and baseline visits.

Критерии исключения

• Known/previous allergy or hypersensitivity.
• Known/previous allergy or hypersensitivity to local anesthetics.
• Previous facial surgery (e.g., facelift) in the treatment area that in the Treating Investigator´s opinion.
• Any previous aesthetic procedures or implants in the treatment area.
• Presence of any disease or lesions in the treatment area.
• An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
• Use of concomitant medication that have the potential to prolong bleeding times.
• Presence of any condition or situation, which in the opinion of the Treating Investigator makes the subject unable to complete the study per protocol.
• Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07344584 · 43CASH2210

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗