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NCT Number: NCT07558603

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

On GLP1 plus HRT

Drug

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.

On GLP1 Only

Drug

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 outcomes

  1. Modified Griffith Scale

    Time frame: Baseline, Week 6 and Week12

    Modified Griffiths 10-point scale to be used for investigator grading of cutaneous signs of photoaging on the face.

    Global Fine Lines. Scale 0 (no fine lines) to 9 (numerous, many fine lines) Overall Hyperpigmentation: Scale 0 (no hyperpigmentation) to 9 (significant hyperpigmentation) Skin Tone Eveness: Scale 0 (very even tone) to 9 (uneven, discolored appearance) Skin Elasticity: Score 0 (skin feels toned and dense) to 9 (skin feels thin and flabby) Skin Firmness: Score 0 (firm, tight feeling) to 9 (loose, lax feeling) Skin Radiance: Score 0 (very radiant, luminous, glowing) to 9 (very dull) Skin Texture: Score 0 (very smooth) to 9 (very rough)

Secondary outcomes

  1. Physician Global Aesthetic Improvement Scale

    Time frame: Week 12

    Physician Grading:

    • Very Much Improved
    • Much Improved
    • Improved
    • No Change
    • Worse
  2. Subject Global Aesthetic Improvement Scale

    Time frame: Week 12

    Subject Grading:

    • Very Much Improved
    • Much Improved
    • Improved
    • No Change
    • Worse
  3. Subject Self-Assessment Questionnaire

    Time frame: Baseline, Week 6 and Week 12

    Circle One

    Skin Feels More Comfortable:

    Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

    Skin Appears Younger Looking:

    Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

    Skin Appears Healthier:

    Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

    Skin Looks Renewed/Revitalized:

    Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

    Skin Looks Firmer:

    Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

    Skin Feels Elastic :

    Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

    Redness Looks Reduced:

    Agree Strongly Agree Neither Agree Disagree Disagree Disagree Strongly

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Pacheco

CONTACT

[email protected]

858-657-1004

Sponsors and collaborators

Lead sponsor

Goldman, Butterwick, Fitzpatrick and Groff

Other

Collaborators

  • L'Oreal

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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