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.
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.
Non post-menopausal state.
Any uncontrolled systemic disease.
History of autoimmune connective tissue disease.
Current use of immunosuppressive medication.
Parallel
On GLP1 plus HRT
DrugAGE 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 Only
DrugAGE 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.
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)
Physician Global Aesthetic Improvement Scale
Physician Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse
Subject Global Aesthetic Improvement Scale
Subject Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse
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
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Goldman, Butterwick, Fitzpatrick and Groff
Lead sponsor
L'Oreal
Collaborator
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