None listed
Conditions
Interventions
Intervention1: Face Cleanser: 1 ml of test product will be used twice a day starting from Day 00 to Day 27.
Application of neutral moisturizer post application of test product
Intervention2: Face Clea
Sponsors
LOr al India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participants with skin phototype IV V (1:1) (Fitzpatrick phototype assessed based on ITA0 value. Measurement Site: Back of the participant) 2) Participants having Body Mass Index in the range of 18 to 25 kg per m2. (Note: BMI can be relaxed to 30 kg per m2 in case of recruitment challenges). 3) Participants having oily skin type, according to the investigator. 4) Participants with oily skin as assessed by Sebumeter (Sebum casual level on centre of the forehead greater than or equal to 100 microgram per cm2). 5) Participants presenting with mild (grade 2) to moderate acne (grade 3) severity on an IGA scale from 0 to 4, according to the investigator. 6) Participants with PIH Spot 3mm and above. 7) Participants presenting acne lesions count: a. greater than or equal to 10 to less than or equal to 25 inflammatory acne lesions on whole face b. greater than 25 to less than or equal to 100 non-inflammatory acne lesions on whole face
Exclusion criteria
Exclusion criteria: 1) Participants with drug induced acne as disclosed by participants. 2) Participants who have used anti acne products in the last 30 days. 3) Participants who are receiving topical or systemic treatments for acne and PIH within the last 30 days. 4) Participants receiving concomitant medications (e.g., steroids or antihistamines)or surgical condition would compromise the study. 5) Participants with chronic illness which may influence the cutaneous state. 6) Participants having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments. 7) Participant having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading. 8) Participants with any pigmentary disorder including freckles and melasma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Dermatological assessment of acne lesions using counting method. 2) Instrumental assessment of the size of PIH 3) Instrumental assessment of Intensity of PIH & Bare SkinTimepoint: 1) Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35. 2) Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35. 3) Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatological assessment of Acne Severity using grading scaleTimepoint: Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.;Dermatological assessment of skin oiliness using grading scaleTimepoint: Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.;Dermatological assessment of Redness around Acne lesion using grading scaleTimepoint: Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.;Dermatological assessment of PIH /Early sign of PIH using grading scaleTimepoint: Day 03, Day 07, Day 14, Day 28 and Day 35.;Instrumental assessment of skin sebum level (SCL and SER)Timepoint: Screening Visit, Day 00 (before application and after application at 15 mins plus 5 mins (only SER assessments), Day 03, Day 07, Day 14, Day 28 and Day 35.;Instrumental assessment of face hydrationTimepoint: Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.;Instrumental assessment of skin barrier functionTimepoint: Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.;Instrumental assessment Overall skin brightness, Redness around acne, acne elevation and on sebaceous poresTimepoint: Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.;Participant Satisfaction Questionnaire (SSA, Health Questionnaire & MWQ)Timepoint: Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.;Assessment of global efficacy and tolerance of investigational products by DermatologistTimepoint: Day 03, Day 07, Day 14, Day 28 and Day 35 | — |
Countries
India
Contacts
Public ContactDr Parth Joshi
Cliantha Research
Outcome results
None listed