Safety & efficacy assessment of products on skin.

Not Applicable

• Registration Number: CTRI/2021/11/038345
• Lead Sponsor: Sun Pharmaceutical Industries 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

1 Having Fitz Patrick Skin type III-IV

2 Having dark spots on face (with at least one dark spot � 3.5mm in diameter) or having visible melasma on face (with mMASI score between 1-8)

3 Having dull skin (i.e., skin that lacks brightness & has uneven skin tone based on visual assessment by experts)

Exclusion Criteria

1Female who is pregnant or breastfeeding or has stopped breastfeeding in the past three months

2Participating in another study liable to interfere with this study

3Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area

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

5Having progressive asthma

Being epileptic

Having non stabilized thyroid problems

Having cutaneous hypersensitivity

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

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) for more than 1 year.

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

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

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)

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

For Smokers - Any change in smoking habits as below

-A person who was a non-smoker but has now started smoking >10 cigarettes per day in the last 6 months

-A person who was smoking <10 cigarettes per day but has started smoking >10 cigarettes per day in the last 6 months

-A person who was smoking >10 cigarettes per day but has now either stopped smoking or is smoking <10 cigarettes per day in the last 6 months

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

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

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

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

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

Having undergone physical and/or chemical treatments of the spots (e.g. liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel) in the previous 6 months

Having a suntanned skin on the studied areas which could interfere with the evaluations of the study

Have taken any other treatment that in the opinion of the investigator could interfere with the evaluations of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified