Safety and efficacy assessment of Product on ski

Not Applicable

• Registration Number: CTRI/2022/09/045260
• Lead Sponsor: SkinQ

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

1.Indian male & 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 and 45 years of age.

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

5.Having tanned minimal forehead.

6.Having uneven skin tone with pigmentation (Acne PIH / Melasma)

Exclusion Criteria

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

2.For Male: Shave beard 1day prior before visit

3.Having refused to give his/her assent by not signing the consent form

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

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

6.Having acne prone skin.

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

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

9.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).

10.Having cutaneous hypersensitivity.

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

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

16.Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during 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 consumed caffeine-based products (coffee, cola, tea, �), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements

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

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

21.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

22.Having applied products with a depigmenting/ whitening 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
Tan reduction, <br/ ><br>reduction in pigmentation and skin smoothnessTimepoint: Baseline, Day14, Day28

Secondary Outcome Measures

Name	Time	Method
Skin brightness and <br/ ><br>Skin even toneTimepoint: Baseline, Day14, Day28