Evaluation of the Safety and efficacy of skin care formulatio

Not Applicable

Registration Number: CTRI/2020/02/023496

Lead Sponsor: Adroit Biomed Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1) Healthy Indian / Asian males and female subjects

2) 36 subjects aged between 18 and 60 years old will be selected for the study

a)Having oily to mixed oily skin on the face

b)Having wheatish to dark complexion &

c)Having atleast one well defined superficial hyper-pigmentory spot ( >3.5mm in diameter)

3) Volunteer willing to participate in the study and provide signed informed consent for the same

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

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

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

18) Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-caroteneâ?¦)

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

20) 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

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

22) Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel â?¦) in the previous 6 months