None listed
Conditions
Interventions
Intervention1: Skin Lightening Face Serum (BSLS-101224): The Product is applied on whole face once at night for the period of 84 days.
Control Intervention1: Nil: NA
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Indian female subjects 2)Having Fitzpatrick Skin type 3 to 5 3)Having facial PIH with at least one dark spot more than or equal to 3mm in diameter. 4)Willing to sign the informed consent form to participate in the study and to comply to the protocol and study procedures
Exclusion criteria
Exclusion criteria: 1)Female who is pregnant or breastfeeding or has stopped breastfeeding in the past three months 2)Participating in another study liable to interfere with this study 3)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 4)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5)Having progressive asthma 6)Being epileptic 7)Having non stabilized thyroid problems 8_Having cutaneous hypersensitivity 9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 10)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. 11)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 12)Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 13)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). 14)Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in pigmentary intensityTimepoint: Baseline, Day 14, Day 28, Day 56 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and cosmetic appealTimepoint: Baseline, Day 14, Day 28, Day 56 and Day 84 | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed