Laxity; SkinNCT07558603
Evaluate the Safety and Efficacy of AGE Serum in Post-menopausal Patients on Hormone Replacement Therapy Taking Glucagon-like Peptide-1 Agonist
A study testing On GLP1 plus HRT and On GLP1 Only in people with Laxity; Skin, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- On GLP1 plus HRT and On GLP1 Only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Dermatology Research Center
San Diego, California, 92121
Andrea Pacheco, 858-657-1004, andrea.pacheco@platinumderm.com
Freia Canals-Cistero, 858-657-1004, freia.canals-cistero@platinumderm.com
About this study
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
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.
- Conditions
- Laxity; Skin
- Being tested
- On GLP1 plus HRT, On GLP1 Only
- Keywords
- GLP1, HRT, Hormone replacement therapy, weight loss, skin laxity, skin texture, skin tone
- Medical subject headings
- Cutis Laxa, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A= On GLP1 plus HRT | Active comparator | Enrolled subjects will receive AGE Serum. Receives: Drug: On GLP1 plus HRT |
| Group B= On GLP1 Only | Sham comparator | Enrolled subject will receive AGE serum Receives: Drug: On GLP1 Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, Week 6 and Week12
Secondary outcomes (3)
Physician Global Aesthetic Improvement Scale
Physician Grading:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse
Measured: Week 12
Subject Global Aesthetic Improvement Scale
Subject Grading:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse
Measured: Week 12
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
Measured: Baseline, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- L'Oreal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558603
- Sponsor's protocol ID
- AGE-SERUM-2025-WAVE2
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07558603
- Acronym / sponsor ID
- AGE-SERUM-2025-WAVE2
- Conditions
- Laxity; Skin
- Keywords
- GLP1, HRT, Hormone replacement therapy, weight loss, skin laxity, skin texture, skin tone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- L'Oreal
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A= On GLP1 plus HRT | Active comparator | Drug: On GLP1 plus HRTEnrolled subjects will receive AGE Serum. |
| Group B= On GLP1 Only | Sham comparator | Drug: On GLP1 OnlyEnrolled subject will receive AGE serum |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On GLP1 plus HRTAGE 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 | Group A= On GLP1 plus HRT |
| On GLP1 OnlyAGE 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 | Group B= On GLP1 Only |
Primary outcome
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)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On GLP1 plus HRT and On GLP1 Only in people with Laxity; Skin, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (858-657-1004, andrea.pacheco@platinumderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Griffith Scale (time frame: Baseline, Week 6 and Week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.