None listed
Conditions
Interventions
Intervention1: CERAVE BRIGHTENING CLEANSER: COCO-BETAINE, DISODIUM LAURETH, SULFOSUCCINATE
SODIUM LAUROYL, SARCOSINATE, NIACINAMIDE
LACTIC ACID, GLYCERIN, LAURETH-4, SALICYLIC ACID, POTASSIUM HYDROXID
Sponsors
L Or al Research & Innovation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy Asian male and female participants aged 18 to 55 years inclusive. At least 33 percent minimum 20 participants must be male. 2.Male and female participants must have very light to no facial hair and agree to keep facial hair the same throughout the study. No moustache or goatee allowed. 3.Participants must have a self perceived skin type with at least 10 percent representation of each type including normal, normal to oily, combination, and oily skin. 4.At least 50 percent of participants must have self perceived sensitive skin. 5.Participants with mild to moderate clinical grading score 3 to 6 according to a modified Griffiths scale for the whole face for Skin tone evenness Global discoloration or hyperpigmentation Global stubborn dark spots including PIH PIE as hyperpigmentation for low phototypes sunspots age spots and general dark spots Rough skin texture visual smoothness Rough skin texture tactile softness Skin clarity Brightness or radiance Enlarged pores Overall skin appearance or quality skin health 6.Participants must have at least one homogeneous well defined stubborn dark spot of at least 3 mm diameter on the face measured using a vernier caliper at screening and baseline visits. 7.Participants must self perceive the following concerns on the face Rough skin texture Dull skin Dark spots or hyperpigmentation Uneven skin tone Visible pores 8.Participants with Phototype II to VI as per ITA classification measured using Chromameter CR 400 on the back. N 5 for phototype II and III N 25 for phototype IV N 25 for phototype V N 5 for phototype VI 9.Participants willing to avoid UV sessions sun tanning sun bathing or any extensive sun exposure during the study. 10.Participants agree to facial waxing or threading one to two days prior to study visits. 11.Participants who use makeup three to seven times a week. 12.Participants who have been using the same skin care and makeup products for at least one month prior to study start. 13.Participants who use SPF five to seven times a week. 14.Participants who use face wash and moisturizer one to two times a day and five to seven times a week. 15.Participants willing to avoid any oral or topical medications that may interfere with study results. 16.Participants must agree to replace their own cleanser and use only the investigational facial cleanser and the provided SPF during the study. 17.Participants must be using a non anti aging cleanser one to two times a day five to seven times a week. 18.Participants able to read write and understand the informed consent document and willing to sign it. 19.Participants willing and able to follow study requirements instructions and schedule. 20.Females of childbearing potential must self declare not pregnant at screening and undergo urine pregnancy tests at Baseline Day 0 Day 28 and Day 56. 21.Females of childbearing potential must either
Exclusion criteria
Exclusion criteria: 1. Participants with any facial permanent makeup or tanning on evaluation areas during the study period. 2. Participants who have undergone any aesthetic surgery on evaluation areas. 3. Participants with moderate to severe melasma. 4. Use of depigmenting retinol vitamin C or AHA based products on evaluation areas within one month. 5. Participants using self tanning products on evaluation areas within one month. 6. Participants using other cosmetic products on evaluation areas within 24 hours before the screening visit. 7. Participants who started hormone replacement therapy or hormonal birth control less than three months before study entry or who plan to start stop or change doses during the study. 8. Participants with any skin condition that may interfere with efficacy evaluation in the investigators opinion. 9. Participants who are pregnant lactating or planning pregnancy during the study. 10. Participants with a history of allergy or hypersensitivity to ingredients of the investigational product. 11. Participants with significant skin pathology in test areas such as rosacea severe acne or eczema. 12. Participants with any significant medical condition that may interfere with study participation. 13. Participants with medical or surgical conditions or medication use that may harm them or interfere with assessments. 14. Participants using topical or systemic treatments that may interfere with the study such as corticosteroids retinoids anti inflammatory drugs or anti aging products. 15. Participants who had dermatological or anti aging procedures such as laser peel dermabrasion photo rejuvenation or facial peeling within six months before study start or during the study. 16. Participants who participated in another clinical study within one month before screening or are currently participating in another study. 17. Participants who cannot be contacted by phone in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the changes in facial skin during the study duration using a modified Griffiths scale 0 equals none 9 equals severe based on clinical grading by the Investigator for the following parameters Skin tone evenness Global discoloration hyperpigmentation Global stubborn dark spots including PIH PIE as hyperpigmentation for low phototypes sunspots age spots and general dark spots Rough skin texture visual smoothness Rough skin texture tactile softness Skin clarity Brightness radiance Enlarged pores Overall skin appearance quality skin health Timepoint: Day 0, Day 3, Day 7, Day 14, Day 28, Day 42, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrumental assessments using Chromameter 400, Skin Cam Pro, VISIA CRTimepoint: Day 0, Day 3, Day 7, Day 14, Day 28, Day 42, Day 56 | — |
Countries
India
Contacts
Public ContactVidushi Bazaz
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed