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

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

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

1. Non post-menopausal state.
2. Any uncontrolled systemic disease.
3. History of autoimmune connective tissue disease.
4. Current use of immunosuppressive medication.
5. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
6. Active dermatitis or active infection in the proposed treatment area.
7. 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.
8. Microneedling treatments of the face and neck during the 1 month period before study treatment
9. 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.
10. Any neurotoxin injection to the face or neck during the 6-month period before study treatment
11. 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.
12. 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.
13. Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment.
14. History of connective tissue disease (e.g., lupus, scleroderma), history of Bell's Palsy, history of smoking.
15. Inability to ambulate following the procedure.
16. Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.
17. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.