跳至主要内容
临床试验/CTRI/2022/12/048265
CTRI/2022/12/048265已完成未知

A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects

Vasu Healthcare Private Limited0 个研究点目标入组 30 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
30

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

  • 1)Age: 25 to 55 years (both inclusive) at the time of consent.
  • 2)Sex: Healthy males and non-pregnant/non-lactating females.
  • 3)Females of childbearing potential must have a self-reported negative pregnancy test.
  • 4)Subject are generally in good health.
  • 5)Subject has a score of at least â??mild skin agingâ?? based on PGA at screening visit.
  • 6)Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
  • 7)Subjects with wrinkles at Crowâ??s feet area.
  • 8)Subjects with uneven texture skin, uneven skin tone, with dry to normal skin only.
  • 9)Subjects with dry skin having <= 40% value as evaluated by MoisturemeterEpiD.
  • 10)Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
  • 11)Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
  • 12)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
  • 13)Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
  • 14)If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
  • 15)If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
  • 16)Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
  • 17)Subjects are willing to give written informed consent and are willing to follow the study procedure.
  • 18)Subjects who have used other marketed products for hair thinning in the past.
  • 19)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.
  • 20)Willing to use test product throughout the study period.

排除标准

  • 1)Subject has a history of allergy or sensitivity to the test treatment ingredients like Kumkumadi tailam, avocado, argan, lavender, rapeseed oil and others etc.
  • 2)Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
  • 3)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
  • 4)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
  • 5)Subject is currently pregnant/breastfeeding.
  • 6)Subject has a history of alcohol or drug addiction.
  • 7)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.
  • 8)Pregnant or breastfeeding or planning to become pregnant during the study period.
  • 9)History of chronic illness which may influence the cutaneous state.
  • 10)Subjects participating in other similar cosmetics, devices or therapeutic trials or skin care products within the last four weeks.

研究者

发起方
Vasu Healthcare Private Limited

相似试验