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| Name | Class |
|---|---|
| L'Oreal | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A= On GLP1 plus HRT | Active Comparator | Enrolled subjects will receive AGE Serum. |
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| Group B= On GLP1 Only | Sham Comparator | Enrolled subject will receive AGE serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Aesthetic Improvement Scale | Physician Grading:
| Week 12 |
| Subject Global Aesthetic Improvement Scale | Subject Grading:
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Inclusion Criteria:
Exclusion Criteria:
This study is tailored towards post-menopausal women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 858-657-1004 | andrea.pacheco@platinumderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center | San Diego | California | 92121 | United States |
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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
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| 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. |
|
| 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 | Baseline, Week 6 and Week 12 |
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020249 | Hormone Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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