A prospective, open-label, 4 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
- 60
- 试验地点
- 1
- 主要终点
- •To assess the safety and efficacy of the product for its non-comedogenic property
研究概览
简要总结
After obtaining the Ethics committeeapproval subjects will be asked to visit the site. Informedconsent will be provided to the studyvolunteers, and after obtaining their consent, the subjects will be asked about their medical history andthe Investigator or his/her designeewill conduct a physical examination. Demographics and vital signs will be recorded. Subjects will be instructed toavoid using their own moisturizersand face serum for at least one week beforecommencement of this study. Once the subjects are found eligible they will be provided with the IP and advised to use ona daily basis. The product efficacyis determined by performing the assessmentslike Pore Indicator Test and assessment of Comedones (GAGS Score). Also Videodermoscopy will be done on Visit 1, Visit2 and Visit 3 which will also help us in seeing the difference in theappearance of comedones. They also will be advisedto fill the feedback questionnaires. The responses obtainedwill be statistically analyzed at the end of the trial to assess the safety and efficacy of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy Indian male/female healthy volunteers aged between 18-55 years.
- •2.Willing to give Informed Consent Form.
- •3.Mild to moderate Black heads on the face 4.Willing to complete the study assessments/questionnaires.
- •5.Willing to avoid usage of his/her own moisturizers and face 6.serum for at least one week before Commencement and during this study.
排除标准
- •1.Pregnancy or breast feeding.
- •2.Patients with pre-existing severe systemic disease necessitating long-term medication.
- •3.Patients with mild to severe Anaphylaxis reactions.
- •4.Evidence of significant uncontrolled co-morbid disease.
- •5.Historyofcancer,includingsolidtumors,hematologic malignancies and carcinoma in situ 6.Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
- •7.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
•To assess the safety and efficacy of the product for its non-comedogenic property
时间窗: Day 1 to Day 28
Following parameters will be evaluated:
时间窗: Day 1 to Day 28
•Appearance of black heads
时间窗: Day 1 to Day 28
•Improvementin Spotcorrection by improving the appearance of large pores
时间窗: Day 1 to Day 28
次要结局
- To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire.(Day 1 to Day 28)