Laxity; Skin
Conditions
Keywords
GLP1, HRT, Hormone replacement therapy, weight loss, skin laxity, skin texture, skin tone
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.
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
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.
Sponsors
Goldman, Butterwick, Fitzpatrick and Groff
L'Oreal
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Post-menopausal 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
1. Non post-menopausal state. 2. Any uncontrolled systemic disease. 3. History of autoimmune connective tissue disease. 4. Current use of immunosuppressive 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 investigational research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Griffith Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Aesthetic Improvement Scale | Week 12 | Physician Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse |
| Subject Global Aesthetic Improvement Scale | Week 12 | Subject Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse |
| Subject Self-Assessment Questionnaire | 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 |
Countries
United States
Contacts
CONTACTAndrea Pacheco
Outcome results
None listed