CTRI/2026/01/100492尚未招募不适用
An Exploratory, Open Label, Interventional, Prospective, Proof-of-Concept Clinical Study to Assess the Safety and Efficacy of Test Product in Female Subjects having Dark Spots, Acne Spots, Sunspots, Age Spots on their face
S H Kelkar and Company Limited1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年1月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
研究概览
简要总结
This exploratory, open-label, interventional, prospective, proof-of-concept clinical study to assess the safety and efficacy of test product in female subjects having dark spots, acne spots, sunspots, age spots on their face.
A total of 33 non-pregnant, non-lactating females aged 18 to 55 years (inclusive), will be enrolled to complete the study.
The subjects will be instructed to visit the facility as per the below visits.
Visit 01: Screening
Visit 02 (Day 01): Enrolment, Baseline Evaluation
Visit 03 (Day 30 +2 Days): Test Product Usage, Evaluations
Visit 04 (Day 60 +2 Days): Final Evaluation, End of Study
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
- •Age: 18 to 55 years at the time of consent.
- •Sex: Adults female subjects having dark spots/pigmentation caused by acne spots, sunspots age spots.
- •Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- •Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin pigmentation in last 6 months.
- •Subjects must be willing to stop using any cosmetics or any medical products for skin pigmentation for the duration of the study.
- •Subjects are not allowed to participate in any other study until this study is complete.
- •Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
- •Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
- •Subjects must agree to record medication use during the study.
排除标准
- •Subjects who are on steroids for last six months.
- •Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last six months.
- •Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
- •Subjects that are pregnant and/or breastfeeding.
- •The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
- •Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
- •The subject has any other skin conditions i.e. cuts, scratches, active acne, ring worms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
- •The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
- •The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
研究者
Dr Apeksha Merja
NovoBliss Research Private Limited
研究点 (1)
Loading locations...
相似试验
已完成
Phase 3 4
A Study to Understand the Usefulness of Cotyledon umbilicus in reducing the pain of sciatica prescribed according to the symptoms given in The Encyclopedia of Pure Materia MedicaCTRI/2024/04/065536Dr MPK Homoeopathic Medical College, Hospital and Research Centre60
已完成
不适用
A Study to Check the Safety and Effectiveness of Dharasana Lep in People with Mild to Moderate Muscle, Joint, or Rheumatic PainCTRI/2025/07/091299Shah Maganlal Chunilal Gandhi35
尚未招募
不适用
A study to test the effect cannabidiol medicine in reducing joint pain and swelling in people with osteoarthritisCTRI/2025/09/094216Unique Therepeutics60
已完成
3 期
A Clinical Study to Assess the Effectiveness of ENO Lime powder in Participants with Symptoms of Acidity and IndigestionCTRI/2025/07/090153Haleon40
招募中
2 期
A clinical study to understand if the Smart Dre-M wound dressing is safe and helps in healing wounds caused by any injury, diabetes, or burns.CTRI/2025/10/096240Neurop Pharma Products Pvt Ltd.25