Open-label Study Evaluating the Safety and Efficacy of AGE Serum in Non-menopausal Patients on Glucagon-like Peptide-1 Agonists
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Modified Griffith Scale
研究概览
简要总结
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.
详细描述
enrolled subjects 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Must be willing to sign a photography release and ICF, and complete the entire course of the study.
- •Subjects in good general health based on the investigator's judgment and medical history.
- •Negative urine pregnancy test result at the time of study entry (if applicable).
- •Subjects of childbearing potential must agree to use an effective method of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
- •A. Acceptable forms of birth control are: oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device/coil, double-barrier methods (e.g., sponge, spermicide, or condoms). Abstinence and/or vasectomized partners must agree to a second acceptable method of birth control (double-barrier) should the subject become sexually active.
- •B. A female is considered of non-childbearing potential if she is: postmenopausal (no menses for at least 12 months), without a uterus (hysterectomy) and/or both ovaries (oophorectomy), or bilateral tubal ligation.
排除标准
- •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).
- •History of autoimmune connective tissue disease.
- •Current use of immunosuppressive medication.
- •Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •Active dermatitis or active infection in the proposed treatment area.
- •Mesotherapy; dermal fillers, biostimulator injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery during the 12-month period before study treatment.
- •Creams/cosmeceuticals and/or home therapies for the prevention or treatment of skin quality in the treatment area during the 1-month period before study treatment.
- •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.
- •Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment.
- •History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease (e.g., lupus, scleroderma), history of Bell's Palsy, epilepsy, smoking, and/or current pregnancy or breastfeeding.
- •Inability to ambulate following the procedure.
- •History of lidocaine and/or epinephrine sensitivity deemed by the investigator to preclude subject from enrolling into study.
- •Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
结局指标
主要结局
Modified Griffith Scale
时间窗: 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)
次要结局
- Physician Global Aesthetic Improvement Scale(Week 12)
- Subject Global Aesthetic Improvement Scale(Week 12)
- Subject Self-Assessment Questionnaire(Baseline, Week 6 and Week 12)