NCT07558603

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Nov 2026

Study Start

First participant enrolled

April 20, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Laxity; Skin

Keywords

GLP1HRTHormone replacement therapyweight lossskin laxityskin textureskin tone

Outcome Measures

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)

    Baseline, Week 6 and Week12

Secondary Outcomes (3)

  • Physician Global Aesthetic Improvement Scale

    Week 12

  • Subject Global Aesthetic Improvement Scale

    Week 12

  • Subject Self-Assessment Questionnaire

    Baseline, Week 6 and Week 12

Study Arms (2)

Group A= On GLP1 plus HRT

ACTIVE COMPARATOR

Enrolled subjects will receive AGE Serum.

Drug: On GLP1 plus HRT

Group B= On GLP1 Only

SHAM COMPARATOR

Enrolled subject will receive AGE serum

Drug: On GLP1 Only

Interventions

On GLP1 plus HRTDRUG

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.

Group A= On GLP1 plus HRT
On GLP1 OnlyDRUG

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.

Group B= On GLP1 Only

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is tailored towards post-menopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cutis LaxaWeight Loss

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Central Study Contacts

Andrea Pacheco

CONTACT

858-657-1004andrea.pacheco@platinumderm.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 50 post-menopausal subjects will be enrolled in to one of two groups, each group will be provided with the exact same products. Group A= On a GLP1 plus an HRT (hormone replacement therapy) Group B= On a GLP1 only
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2026

First Posted

April 30, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

US(1)