Safety & efficacy assessment of products on skin.

Not yet recruiting

• Conditions: Volunteers having Melasma or Dark spots

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

Brief Summary

**Primary Objective:**

Toassess the efficacy of skin care regime with combination of Bristaa IntenseCream and Photostable Gold Sunscreen Gel in female subjects with melasma anddark spots.

 **SecondaryObjective:**

1.    To assess the safety of skin care regime withcombination of Bristaa Intense Cream and Photostable Gold Sunscreen Gel infemale subjects with melasma and dark spots

2.    To evaluate the cosmetic appeal of

a.     Photostable GoldSunscreen Gel

Combination of Bristaa Intense Cream andPhotostable Gold Sunscreen Gel

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 124

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. phenytoïn, 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

Primary Outcome Measures

Name	Time	Method
Safety & Efficacy assessment of products	Screening T0, T28 days , T42 days T56 days, T70 days and T90 days

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 (Suburban), MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳(Suburban), MAHARASHTRA, India

Dr Raji Patil

Principal investigator

022-43349191

raji@mascotspincontrol.in