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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
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
50
estimated
Study population
Healthy volunteers
Key I/E criterion
•Female
Primary endpoint
•Modified Griffith Scale
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Patient-reported / QoL
2 endpointsSubject Global Aesthetic Improvement Scale
Time frame:Week 12
PGI, change
categorical status, improvement
Subject Self-Assessment Questionnaire
Time frame:Baseline, Week 6 and Week 12
descriptive, improvement
Other clinical outcomes
2 endpointsModified Griffith Scale
Time frame:Baseline, Week 6 and Week12
change from baseline, improvement
Physician Global Aesthetic Improvement Scale
Time frame:Week 12
categorical status, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.