Evaluate the Safety and Efficacy of AGE Serum in Post-menopausal Patients on Hormone Replacement Therapy Taking Glucagon-like Peptide-1 Agonist

Официальное название

A Prospective, Single Center, Open-label Study Evaluating the Safety and Efficacy of AGE Serum in Post-menopausal Patients on Hormone Replacement Therapy Taking Glucagon-like Peptide-1 Agonists

Обзор

The primary objective is to assess the safety and efficacy of the AGE Serum in improving the appearance of skin in post-menopausal subjects on HRT and non-HRT who are takingGLP-1 agonist therapy through the use of investigator assessments, subject questionnaires/assessments, photography, skin imaging, and reported adverse reactions.

Подробное описание

Enrolled subjects will be in one of two groups, they will apply a topical serum (AGE Serum) to the full face and neck twice daily for 12 weeks. Subject follow-up visits will occur at Week 6 and Week 12. Subjects will complete assessments and participate in and standardized 2D and 3D (Visia) digital photography.

Вмешательства

• Препарат On GLP1 plus HRT
  AGE serum is a topical that contains a high concentration of 30% Proxylane and a synergistic blend of fruit-derived flavonoids (blueberry, pomegranate) and Cassia alata extract.
• Препарат On GLP1 Only
  AGE serum is a topical that contains a high concentration of 30% Proxylane and a synergistic blend of fruit-derived flavonoids (blueberry, pomegranate) and Cassia alata extract.

Первичные конечные точки

• Modified Griffith Scale [Срок оценки: Baseline, Week 6 and Week12]

Вторичные конечные точки (3)

• Physician Global Aesthetic Improvement Scale [Срок оценки: Week 12]
• Subject Global Aesthetic Improvement Scale [Срок оценки: Week 12]
• Subject Self-Assessment Questionnaire [Срок оценки: Baseline, Week 6 and Week 12]

Критерии участия

Критерии включения

• Post-menopausal women (25 on HRT, 25 non HRT all must be post-menopausal)
• Presence of mild to moderate signs of facial aging (e.g., fine lines, laxity, dull texture) based on modified Griffith scale.
• Adult women aged 45-65 years.
• Fitzpatrick skin types I-VI.
• Current treatment with a stable dose of any GLP-1 agonist medication, including Ozempic, Rybelsus, or Wegovy for at least the last 3 months
• Must be willing to sign a photography release and ICF,and complete the entire course of the study.
• Subjects in good general health based on the investigator's judgment and medical history.

Критерии исключения

• Non post-menopausal state.
• Any uncontrolled systemic disease.
• History of autoimmune connective tissue disease.
• Current use of immunosuppressive medication.
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• Active dermatitis or active infection in the proposed treatment area.
• Mesotherapy; dermal fillers, biostimulator injectables; radiofrequency device treatments; microfocused ultrasound device treatments; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery during the 12-month period before study treatment.
• Microneedling treatments of the face and neck during the 1 month period before study treatment
• Laser and light based device treatments of the face and neck. Ablative lasers 6-month period before study treatment, and 3-month period for non-ablative lasers.
• Any neurotoxin injection to the face or neck during the 6-month period before study treatment
• Subjects using any treatment skincare products must discontinue use of these products 2 weeks before the start of participating in this clinical study and for the duration of the study.
• Subjects with scarring in the treatment areas, which in the opinion of the investigator could impact results. Subjects with a history of keloids will be excluded.
• Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment.
• History of connective tissue disease (e.g., lupus, scleroderma), history of Bell's Palsy, history of smoking.
• Inability to ambulate following the procedure.
• Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• West Dermatology Research Center — San Diego

Идентификаторы

NCT: NCT07558603 · AGE-SERUM-2025-WAVE2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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