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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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.
West Dermatology Research Center
San Diego, California, United States
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)
Time frame: Baseline, Week 6 and Week12
Physician Global Aesthetic Improvement Scale
Physician Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse
Time frame: Week 12
Subject Global Aesthetic Improvement Scale
Subject Grading: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse
Time frame: 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
Time frame: Baseline, Week 6 and Week 12
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