A Prospective, open-label, one arm study to evaluate the safety and efficacy of Skin care product for its non-comedogenic effect in healthy male or female volunteers.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Primary Outcomes:
研究概览
简要总结
Comedones are the skin-colored, small bumps (papules) frequently found on the forehead and chin of those with acne. A single lesion is a comedon. There are different types of comedones as follows,
Open comedones are blackheads; black because of surface pigment (melanin), rather than dirt.
Closed comedones are whiteheads; the follicle is completely blocked.
Microcomedones are so small that they are not visible to the naked eye.
Macrocomedones are facial closed comedones that are larger than 2–3 mm in diameter.
A giant comedo is a type of cyst in which there is a clear blackhead-like opening in the skin.
Solar comedones are found on the cheeks and chin of older people, and are thought to be due to sun damage
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •• Healthy Indian male and female healthy volunteers aged between 18-55 years.
- •• Willing to give Informed Consent Form.
- •Subjects with Clear to mild skin condition according to GAGS score 0 to
- •• Willing to complete the study assessments questionnaires.
- •• Willing to avoid usage of his or her own moisturizers and face Cream for at least one week before Commencement and during this study.
排除标准
- •Pregnancy or breast feeding.
- •• Patients with pre existing severe systemic disease necessitating long-term medication.
- •• Patients with mild to severe Anaphylaxis reactions.
- •• Evidence of significant uncontrolled co-morbid disease.
- •• History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ • Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
- •• Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
结局指标
主要结局
Primary Outcomes:
时间窗: Day 0, Day 15, Day 30.
1.Percentage evaluation in Global Acne Grading System (GAGS Score)
时间窗: Day 0, Day 15, Day 30.
2.Evaluation of blocked pores through pore indicator test.
时间窗: Day 0, Day 15, Day 30.
3.Visual observation of Comedones through Videoscopy.
时间窗: Day 0, Day 15, Day 30.
4.Evaluation of cutaneous melanin by Mexameter.
时间窗: Day 0, Day 15, Day 30.
次要结局
- To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.(Day 0, Day 15, Day 30.)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt Ltd.