Effectiveness of CGB-400 (Cosmetic) for the Reduction of Facial Redness and Bumps and Blemishes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Investigator's Global Assessment (IGA)
研究概览
简要总结
Open-label multicenter study using CGB-400 Gel to reduce facial redness, bumps, and blemishes.
详细描述
This is a Open-label multicenter study to evaluate the ability of CGB-400 Gel to reduce facial redness and bumps/blemishes typically associated with rosacea. Approximately 25 subjects will be enrolled.
Subjects will receive study treatment for 12 weeks and attend a total of 5 study visits (i.e., BL, W2, W4, W8, W12).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline and practice a reliable method of contraception throughout the study.
- •Facial redness associated with rosacea with or without bumps or blemishes.
- •Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).
- •IGA score of 2 or 3 (i.e., mild or moderate).
- •Absence of any skin conditions that could interfere with the visual erythema assessments.
- •Willing to forego any other topical or non-topical treatment on the study areas during treatment (other than sun protection or the study specified face wash and moisturizer).
- •Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over the duration of the study.
- •Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures being performed.
排除标准
- •Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.).
- •Any transient flushing syndrome.
- •History of basal cell carcinoma within 6 months of Visit
- •History or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.).
- •Diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans at Baseline.
- •Blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist.
- •Uncontrolled systemic disease.
- •Foreseen unprotected and intense/excessive UV exposure during the course of the study.
- •Use of any of the following concomitant medications/procedures:
- •Cosmetic and/or OTC products for redness reduction and/or skin clearing
- •Topical medications for rosacea
- •Systemic antibiotics or corticosteroids
- •Topical antibiotics, corticosteroids, or antiparasitic agents
- •Intense/excessive ultraviolet (UV) radiation
- •Phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion
- •Exposure to any other investigational drug/device within 30 days prior to study entry.
研究组 & 干预措施
Subjects with redness and bumps and/or blemishes
Topical administration twice daily for 12 weeks
干预措施: CGB-400 (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA)
时间窗: Week 12
5-point scale (0 - Clear skin with no signs of bumps/blemishes; 1 - Almost clear; minimal lesions (\<5 bumps/blemishes); 2 - Mild facial lesions (6-10 bumps/blemishes): 3 - Moderate lesions; marked redness (11-25 bumps/blemishes): 4 - Severe lesions; fiery redness (\>25 bumps/blemishes)
Investigator's Global Assessment of Redness (IGA-R)
时间窗: Week 12
5-point scale (0 - Clear skin with no signs of redness to 4 - Severe; fiery redness)
次要结局
- Investigator's Global Assessment (IGA)(Day 0, Week 2, Week 4, Week 8)
- Investigator's Global Assessment of Redness (IGA-R)(Day 0, Week 2, Week 4, Week 8)
- Bumps/Blemishes Count(Day 0, Week 2, Week 4, Week 8, Week 12)
- Patient Global Assessment(Day 0, Week 2, Week 4, Week 8, Week 12)