A prospective, open-label, one arm study to evaluate the safety and efficacy of Efatop HYDRA GEL for its noncomedogenic 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
- 20
- 试验地点
- 1
- 主要终点
- • To assess the safety and efficacy of skin care product for its non-comedogenic property.
研究概览
简要总结
After the Ethics committee approval subjects will be asked to visit the site. Informed consent will be provided to the study volunteers, and after obtaining their consent, the subjects will be asked about their medical history and the Investigator or his/her designee will conduct a physical examination. Demographics and vital signs will be recorded. Subjects will be instructed to avoid using their own skin care products for at least one week before commencement of this study. Once the subjects are found eligible they will be provided with the IP and advised to use on a daily basis. The product efficacy is determined by performing the assessments like GAGS score, Pore Indicator Test and Videoscopy will be done on Visit 1, Visit 2 and Visit 3. Subjects will be advised to fill the feedback questionnaires on Visit 3. The responses obtained will 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
- 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
- •1.Healthy Indian male/female healthy volunteers aged between 18-55 years.
- •2.Willing to give Informed Consent Form.
- •3.Subjects with Clear to mild skin condition according to GAGS score 0 to
- •4.Willing to complete the study assessments/questionnaires.
- •5.Willing to avoid usage of his/her own skin care products 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.History of cancer, including solid tumours, 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 skin care product for its non-comedogenic property.
时间窗: Day 0 to Day 30
Following parameters will be evaluated:
时间窗: Day 0 to Day 30
• Appearance of black heads through Videoscopy.
时间窗: Day 0 to Day 30
• Assessments of blocked pores through pore indicator test.
时间窗: Day 0 to 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 to Day 30)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt. Ltd