None listed
Conditions
Interventions
Intervention1: Facial cleanser: Product A Facial cleanser FLA No 202151323 on half-face (treated site) for 12 hours
Product B Facial cleanser FLA No 20215006V01 on half-face (treated site) for 12 hou
Sponsors
LOreal Research & Innovation
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy Indian and Caucasian male and female participants aged 18 to 55 years minimum 20 percent male participants 2 Skin phototype I and II for CIDP Romania and III to VI for CIDP India assessed using Chromameter CR400 on unexposed back area 3 Participants with mild to moderate facial shine score 3 to 6 on a 10 point modified Griffiths scale on global face and each half face 4 Participants with one hundred percent self perceived oily skin and appearance of shine 5 At least 20 participants with self perceived sensitive skin including 12 from India and 8 from Romania 6 Forehead sebumeter value between 121 to 250 microgram per square centimeter on each half face 7 Participants willing to avoid washing hair for 24 hours prior to visits 8 Participants willing to avoid face washing and use of skincare or makeup products from midnight before baseline visit and on visit morning 9 Participants willing to refrain from washing wiping or touching face during study visits 10 No participation in any clinical study within the past 4 weeks 11 Participants willing to remain sequestered at the test facility for 14 to 15 hours and avoid hot food or drinks for 30 minutes prior to assessments 12 Male participants with minimal or no facial hair willing to maintain same throughout study and avoid shaving for 24 hours prior to visits 13 Agreement for facial waxing or threading 1 to 2 days prior to visits 14 Stable use of personal skincare and makeup products for at least 1 month prior to study initiation 15 Willingness to avoid oral or topical medications that may interfere with study outcomes 17 Participants able to read write and understand the informed consent document and willing to provide written informed consent 18 Participants willing and able to comply with study requirements instructions and study schedule 19 Female participants of childbearing potential with self declared non pregnancy at screening and willing to undergo urine pregnancy test at both baseline visits D0T0 baseline one and baseline two 20 Female participants of childbearing potential who are not sexually active or who are using an effective contraceptive method except systemic contraception for at least one month prior to study initiation and throughout the study
Exclusion criteria
Exclusion criteria: 1 Participants with active facial dermatitis eczema psoriasis rosacea or other chronic skin disorders 2 Participants with severe acne including nodulocystic or conglobate acne or other inflammatory skin conditions 3 Participants with open wounds scars tattoos or permanent makeup on evaluation areas 4 Participants with history of hypersensitivity allergy or intolerance to cosmetic cleansers AHA or any investigational product ingredients 5 Participants with significant systemic illness such as uncontrolled diabetes immune disorders or endocrine disorders affecting skin or sebum 6 Participants who have used systemic or topical retinoids antibiotics corticosteroids hormonal treatments or anti androgens within the last 3 to 6 months 7 Current use of sebum control products acne treatments anti dandruff shampoo or investigational products within 4 weeks prior to screening 8 Participants who have undergone chemical peels laser resurfacing or dermabrasion within the last 3 months 9 Participants using self tanning products on evaluation areas within 1 month prior to screening 10 Participants with excessive sun or UV exposure tanning bed use or planned sun exposure during the study period 11 Participants who have received facial cosmetic procedures or aesthetic surgery such as fillers or botulinum toxin within the last 6 months 12 Participants who are pregnant lactating or planning pregnancy during the study with self declaration at screening and urine pregnancy test at both baseline visits baseline one and baseline two 13 Participants unwilling or unable to comply with sequestered study conditions including prolonged stay dietary restrictions or face washing restrictions 14 Male participants with dense facial hair interfering with shine or sebum assessments 15 Participation in another clinical trial within 4 weeks prior to screening 16 Participants using other cosmetic products or washing face on evaluation areas within 24 hours before screening 17 Participants with any concomitant medical or surgical condition or using medications that may harm the participant or interfere with study assessments as per investigator judgment 18 Participants unable to be contacted by phone in case of emergency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the efficacy of two facial cleansers Product A and Product B versus untreated split face design in sebum control and appearance of skin shine over a 12 hour period with a two week washout between each test product using 1 Sebumeter measurements at three points across each half of the forehead compared to baseline and untreated half face 2 Clinical grading of skin shine on each half face compared to baseline and untreated half faceTimepoint: Washout phase (Day -7 to Day-1) Week 0 Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 VISIA CR imaging using cross polarized parallel polarized and standard views at different time points 2 To monitor overall cutaneous safety and tolerability as perceived by participants during the study period by assessing local intolerance adverse events and serious adverse eventsTimepoint: Day -7 to Day -1 Day 0 | — |
Countries
India
Contacts
Public ContactAbhishek Kashyap
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed