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Not yet recruiting NCT07558603

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

No phase Interventional Laxity; Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: On GLP1 plus HRT, On GLP1 Only.
Who it may be relevant to
Registry conditions: Laxity; Skin. Basic parameters: 45 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Modified Griffith Scale [Time frame: Baseline, Week 6 and Week12]
Secondary outcome measures (3)
  • Physician Global Aesthetic Improvement Scale [Time frame: Week 12]
  • Subject Global Aesthetic Improvement Scale [Time frame: Week 12]
  • Subject Self-Assessment Questionnaire [Time frame: Baseline, Week 6 and Week 12]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • West Dermatology Research Center — San Diego

Identifiers

NCT: NCT07558603 · AGE-SERUM-2025-WAVE2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗