Safety and efficacy check of Product on ski

Not Applicable

Completed

• Registration Number: CTRI/2023/02/049829
• Lead Sponsor: BRIGHT LIFECARE PVT. LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-30
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

The study will be conducted on subjects who will fulfill the following criteria:

1.Indian / Asian female subjects

2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)

3.Between 18 to 35 years and above.

4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)

5.Having dull skin.

6.Having wheatish to dark complexion

Exclusion Criteria

1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months

2.Having refused to give her assent by signing the consent form

3.Taking part in another study liable to interfere with this study

4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area

5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)

6.Having a progressive asthma (either under treatment or last fit in the last 2 years)

7.Being epileptic

8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)

9.Having cutaneous hypersensitivity

10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex

11. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)

12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit

14.Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).

15.Refusing to follow the restrictions below during the study:

- Do not take part in any family planning activities leading to pregnancy and breastfeeding

- Do not take part in another study liable to interfere with this study

- Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)

- Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit

- During the study: Do not use other cosmetic products than the tested products to the studied areas (only usual cleanser/soap is accepted)

- The day of the measurements: No test product must be used (only face cleaned with water is accepted)

16.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months.

17.Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months

18.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months

19.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)

20.Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or having applied self-tanning products in the week preceding the start of the study

21.Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study

22.Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.

23.Having undergone physical and/o

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the in-vivo efficacy and safety of a skin care regime in terms of skin brightening & skin radiance on healthy female subjects.Timepoint: Baseline, day 14 , Day 28

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Not applicable