A Single Centric, Open Label, Non Randomized Phase IV Post Marketing Surveillance Study to Measurethe Efficacy and Safety of Roop Mantra Ayurvedic Medicinal Cream on Subjects Suffering from Acne,Face Scars, Pimples, Blemishes, Dull & Dry Skin
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1.Assessment of Skin Recovery (Change from Baseline) over a period of 60 Days in the Subjects who have undergone in topical application of Roop Mantra Ayurvedic Medicinal Cream.
研究概览
简要总结
The Study has been designed to evaluate the efficacyof Roop Mantra Ayurvedic Medicinal Cream in adult human subject in order tocheck the Safety and evaluate the benefits of product Roop Mantra AyurvedicMedicinal Cream as per dermatological parameters.Thestudy is an Open label, Single armed, Single centric, Non-randomized, Phase IVPost marketing surveillance study on 120 subjects.
There are three visitsin the study. On screening visit i.e., day 1, the subjects will be screenedbased on inclusion and exclusion criteria. Eligible subjects will be briefedwith the study procedure and a member from the study team will explain thesubject about all study related procedure. An informed consent form will givento all subject at screening visit containing all study information in it.Eligible subjects will be enrolled into the study after informed consentprocedure. The site Investigator will explain the subject about all studyrelated process and the visit 2 – Day 30 and Visit 3 Day 60(Final Visit). All eligible subjects will be then providedwith Test Product – Roop Mantra Ayurvedic Medicinal Cream by Investigator/studyteam member. In the presence of Investigator, the instructions will be given touse the test product at home from Day 1 to Day 60 i.e. Apply a small amount ofthis product (an amount equal to the surface area of the tip of a finger)&message gently over cleansed face twice a day, preferably morning and eveningfor 60 days**.**
Adermatological evaluation /assessment shall be performed on Baseline Day 0 andfinal visit Day 60. A self-assessment questionnaire shall be given to alleligible subjects on Baseline and Final visit. This is an open label, nonrandomized study involving healthy volunteers between age 18-45 years.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age Between 18-45 Years.
- •2.Male and Female Subjects with general physical good Mental Condition.
- •3.Willingness to take part in study and able to attend all scheduled visits.
- •4.Skin type with Acne, Facial Scars, pimples, blemishes, dull& dry skin complexion.
排除标准
- •1.Pregnant, Breastfeeding, subjects undergone any surgery and else take taken part in any cosmetic clinical trial.
- •2.Not willing to Sign the ICF or give the consent.
- •3.Mole, tattoos or any kind of allergy on the skin due to external or internal factor.
- •4.Any kind of Ocular Disorder and Ocular Surgery 5.Use of facial bleach, facial scrub, hair removal or any other product within 2 weeks prior to screening.
结局指标
主要结局
1.Assessment of Skin Recovery (Change from Baseline) over a period of 60 Days in the Subjects who have undergone in topical application of Roop Mantra Ayurvedic Medicinal Cream.
时间窗: 1.Assessment of Skin Recovery (Change from Baseline) over a period of 60 Days in the Subjects who have undergone in topical application of Roop Mantra Ayurvedic Medicinal Cream. | 2.Assessment of Skin recovery and removal of Scars from baseline over a period of 60 days.
2.Assessment of Skin recovery and removal of Scars from baseline over a period of 60 days.
时间窗: 1.Assessment of Skin Recovery (Change from Baseline) over a period of 60 Days in the Subjects who have undergone in topical application of Roop Mantra Ayurvedic Medicinal Cream. | 2.Assessment of Skin recovery and removal of Scars from baseline over a period of 60 days.
次要结局
- 3.Self-assessment questionnaire filled by Subject shall be taken from Baseline to Final Visit to show the change in skin type designed on any parameter(at the end of 30 days and at the end of 60 days)