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Not yet recruitingPhase NA

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

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

NCT IDNCT07558603
Org study IDAGE-SERUM-2025-WAVE2

Timeline

Milestones

Study start2026-04-20estimated
Study first posted2026-04-30actual
Last update posted2026-04-30actual
Primary completion2026-08-30estimated
Study completion2026-11-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age45 Years
Maximum age65 Years
SexFemale
Healthy volunteersAccepted

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
Other clinical outcomes
2

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Subject Global Aesthetic Improvement Scale

Time frame:Week 12

PGI, change

categorical status, improvement

Secondary/protocol endpoint

Subject Self-Assessment Questionnaire

Time frame:Baseline, Week 6 and Week 12

descriptive, improvement

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

Modified Griffith Scale

Time frame:Baseline, Week 6 and Week12

change from baseline, improvement

Secondary/protocol endpoint

Physician Global Aesthetic Improvement Scale

Time frame:Week 12

categorical status, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.