A clinical study to assess the safety and effectiveness of collagen-containing test products in healthy adult Human subjects
- Registration Number
- CTRI/2022/11/047566
- Lead Sponsor
- Bright LifeCare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Crow feet area wrinkles using VisioScan VC 20Timepoint: From baseline to Day 28 and Day 56
- Secondary Outcome Measures
Name Time Method Change in Glogau Skin Age as evaluated by the dermatologistTimepoint: From baseline to Day 28 and Day 56;Change in hair fall by 60-second hair comb testTimepoint: From baseline to Day 28 and Day 56;Change in PGA scoring using Griffiths scale [i.e., Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness]Timepoint: From baseline to Day 28 and Day 56;Change in skin color using Skin-Colorimeter CL 400Timepoint: From baseline to Day 28 and Day 56;Improvement in hair strength by Pull testTimepoint: From baseline to Day 28 and Day 56;Improvement in skin elasticity using DermaLab ComboTimepoint: From baseline to Day 28 and Day 56;Improvement in skin hydration using MoitureMeterEPiDTimepoint: From baseline to Day 28 and Day 56;Noticeable improvement from before and after photographsTimepoint: From baseline to Day 56;To assess the subject perception about treatmentTimepoint: From baseline before treatment to Day 28 and Day 56 post treatment