About this trial
The primary objective is to evaluate the safety and efficacy of a topical serum (AGE serum) in improving visible signs of aging (e.g., fine lines, wrinkles, sagging, texture, radiance) on the full face and neck.The study will be conducted in non-menopausal female and male subjects who are on glucagon-like peptide-1 (GLP-1) agonist therapy for weight loss.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Presence of mild to moderate signs of facial aging (e.g., fine lines, laxity, dull texture) based on modified Griffith scale.
Adult men and women aged 25-50 years.
Fitzpatrick skin types I-IV.
Current treatment with a stable dose of GLP-1 agonist medication, including Ozempic, Rybelsus, or Wegovy for at least last 6 months.
Disqualifiers
Pregnancy or planned pregnancy during the study or currently breastfeeding.
Current menopausal state.
Any uncontrolled systemic disease.
Current use of other GLP-1 agonist therapy aside from the GLP-1 agonist class of medications (Ozempic, Rybelsus, or Wegovy).
Trial design
Single group
Treatments tested in this trial
AGE Serum
Other interventionAGE 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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
Sponsors and contacts
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Goldman, Butterwick, Fitzpatrick and Groff
Lead sponsor
L'Oreal
Collaborator
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