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HomeTrials › NCT07558603

Other · Not applicable · Opening soon

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

NCT07558603 · Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

What this trial means for you

This study is opening soon at 1 US site. It's studying On GLP1 plus HRT, On GLP1 Only for laxity; skin.

Who can joinWomen, 45 Years – 65 Years
Healthy volunteersAccepted
What you'd takeOn GLP1 plus HRT, On GLP1 Only
Study length~4 months overall
Planned participants50
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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.

Study sites by state

California

  • West Dermatology Research Center — San Diego

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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