ClinicalTrials.gg
Not yet recruitingNCT07558603Updated Apr 30, 2026

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

An interventional study of On GLP1 plus HRT and On GLP1 Only in Laxity; Skin, sponsored by Goldman, Butterwick, Fitzpatrick and Groff. Not yet recruiting at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Goldman, Butterwick, Fitzpatrick and Groff · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Laxity; Skin

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Keywords

  • GLP1
  • HRT
  • Hormone replacement therapy
  • weight loss
  • skin laxity
  • skin texture
  • skin tone
03

In context

Weight Loss

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Goldman, Butterwick, Fitzpatrick and Groff is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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

Exclusion Criteria:

  1. Non state.
  2. Any uncontrolled systemic disease.
  3. History of connective tissue disease.
  4. Current use of 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 research study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Group A= On GLP1 plus HRT

    Enrolled subjects will receive AGE Serum.

    Drug: On GLP1 plus HRT

  • Sham comparator
    Group B= On GLP1 Only

    Enrolled subject will receive AGE serum

    Drug: On GLP1 Only

Interventions

  • DrugOn 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.

  • DrugOn 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.

06

What researchers measure

Primary outcomes

  1. Modified Griffith Scale

    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)

    Time frame: Baseline, Week 6 and Week12

Secondary outcomes

  1. Physician Global Aesthetic Improvement Scale

    Physician Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse

    Time frame: Week 12

  2. Subject Global Aesthetic Improvement Scale

    Subject Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse

    Time frame: Week 12

  3. Subject Self-Assessment Questionnaire

    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

    Time frame: Baseline, Week 6 and Week 12

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Aug 2026, 4 months later.

Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 4 months is below that.

Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2026
First posted
Apr 30, 2026
StartEst.
Apr 20, 2026
Primary completionEst.
Aug 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Apr 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07558603
Lead sponsor
Goldman, Butterwick, Fitzpatrick and Groff
Collaborators
L'Oreal
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
Apr 20, 2026 (estimated)
Primary completion
Aug 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Apr 30, 2026

Study contacts

Andrea Pacheco
Contact
andrea.pacheco@platinumderm.com
858-657-1004

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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