Evaluation of safety and efficacy of skin care formulatio

Not Applicable

• Registration Number: CTRI/2022/08/044838
• Lead Sponsor: DPKA Universal Consumer Ventures Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1Indian Female subjects.

2Healthy 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)

3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar, acne�.) Specific criteria

4Having wheatish to dark complexion.

5Having dry skin.

6Subjects who are passing in skin sensitivity test (only for 13 females)

Exclusion Criteria

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

2Having refused to give her assent by not signing the consent form

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

4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)

5Having a progressive asthma (either under treatment or last fit in the last 2 years)

6Being epileptic.

7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)

8Having cutaneous hypersensitivity

9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.

10Following 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)

11Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

12Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit

13Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted)

14Refusing 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 or skin care products other than the tested products to the studied areas. (only standard facewash is accepted). The day of the measurements: No test product must be used (only face cleaned with water is accepted) Specific criteria

15Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months.

16Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months

17Having taken a medicinal treatment which could lead to hyper pigmentation (phenyto�¯n, amiodarone, metals, minocyclineâ�¦) in the previous 6 months

18Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene�)

19Having 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

20Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study

21Having applied products with a depigmenting action (hydroquinone or derivates�) in the 4 weeks preceding the start of the study.

22Having undergone physical and/or chemical treatments of the spots (liquid ni

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
skin brightening, skin safetyTimepoint: Baseline, 30 min after product application, 7 days, 14 days and 28 days

Secondary Outcome Measures

Name	Time	Method
improvement in skin hydration <br/ ><br>and improvement in skin smoothnessTimepoint: Baseline, 30 min after product application, 7 days, 14 days and 28 days