CTRI/2013/06/003780已完成未知
An open label, monocentric, pilot study to evaluate the safety and efficacy of anti ageing product in healthy adult female subjects with skin type III to V. - NI
Sami Labs P Ltd0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Female adult subjects in general good health as determined from
- •a recent medical history.
- •2. Subjects in the age group of 30 - 50 years (both ages inclusive).
- •3. Subjects with Fitzpatrickâ??s skin types III, IV, and V.
- •4. Subjects having visible fine lines and wrinkles, i.e,
- •Glabellar frownlines/Crowâ??s feet/nasolabial folds/forehead lines
- •and perioral wrinkles or few or all of them.
- •5. Subjects who have not under gone any facial anti ageing
- •procedures (e.g. Botulinum toxin, dermal filler injections, laser
- •resurfacing) in the past 1 year.
- •6. Subjects willing to discontinue use of topical anti ageing
- •products within 30 days before enrolling into study and not on
- •any oral anti ageing products such as anti oxidants,
- •green tea, etc 3 months before enrollment into study.
- •7. Subject who are willing to abstain from spa treatments/facials
- •during the study Period.
- •8. Subjects who have not undergone facial/spa treatment 2 weeks
- •before enrollment.
- •9. Subjects willing to give a voluntary written informed consent
- •and agree to come for regular follow up.
- •10. Subjects willing to abide by and comply with the study
- •11. Subjects who have not participated in a similar investigation in
- •the past four weeks.
- •12. Subjects who are willing not to participate in any other clinical
- •study during participation in the current study.
- •13. In addition, female subjects selected for the study must:
- •Be using a medically acceptable form of birth control for the
- •duration of the study as judged by the investigator(s) Or
- •Be surgically sterile Or
- •Be post menopausal for at least 1 year
- •And have a negative urine pregnancy test at the screening visit
排除标准
- •1.A known history or present condition of allergic
- •response/hypersensitivity to any cosmetic ingredients,pharmaceutical products or any ingredient of the IP.
- •2. Female subjects with positive pregnancy test or not practicing contraception and nursing mothers.
- •3. History of intense sun exposure.
- •4. Presence of any underlying, clinically significant uncontrolled medical illness.
- •5. Subject having active skin diseases
- •6. Subject participating in any other cosmetic or therapeutic study.
研究者
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