CTRI/2022/11/047566已完成未知
A Randomized, Double-blind, Three-arm, Comparative, Parallel, Proof-of-Concept Study to Evaluate Safety and Efficacy of Collagen containing Test Products in Healthy Adult Human Subjects
Bright LifeCare Private Limited0 个研究点目标入组 56 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
- 56
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: 38 to 50 years (both inclusive) at the time of consent.
- •2)Sex: Healthy 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 with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
- •6)Subject has a score of at least â??mild skin agingâ?? based on PGA at screening visit.
- •7)Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
- •8)Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
- •9)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.
- •10)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- •11)Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
- •12)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.
- •13)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.
- •14)Subjects are willing not to introduce any new soaps, cleansers, lotions, creams, or any other face product etc. for the duration of the study.
- •15)Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •16)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.
- •2)Subjects who has a history of Fish allergy.
- •3)Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the investigator.
- •4)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.
- •5)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- •6)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- •7)Subject is currently pregnant/breastfeeding.
- •8)Subject has a history of prior use of skin radiance or wrinkle laser treatment within 3 months.
- •9)Subject has a history of alcohol or drug addiction.
- •10)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.
- •11)Pregnant or breastfeeding or planning to become pregnant during the study period.
- •12)Subjects participating in other similar cosmetics, devices or therapeutic trials or skin care products within the last four weeks.
研究者
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