None listed
Conditions
Interventions
Intervention1: Product A: CNWOSS1(face cleanser)
Product B: CNSSSA2 (face cleanser)
Product C: CTIOVA 3(face cleanser)
Product D: CLTTBS4S (Soap bar): The investigational products are face cleanser an
Sponsors
LOreal India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy female Indian volunteers, aged 18 â?? 45 years (both inclusive) 2. Subjects with casual sebum levels >= 80 μg/cm2 and Sebum Excretion Rate >= 50 μg/cm2 3. Subjects having atleast 5 inflammatory and no more than 15 inflammatory lesions over the whole face, out of which atleast 2 are papules of size > 0.5 mm and evolved in last 5 days (basis the medical history) 4. Subjects having at least 10 non-inflammatory acne lesions and not more than 50 non-inflammatory acne lesions over the whole face, out of which at least 50% are open comedones (black heads) 5. Subjects with medium to dark skin color having ITA values between >= 10 and 6. Subjects having at least two Post Inflammatory Hyper pigmentation spots of size 3 mm or more 7. Subjects with adequate representation of normal and sensitive skin 8. Females with a stable hormonal status, as self-declared by subjects 9. Subject who agrees not to use any other product/treatment/soap bar/any other cleanser on their face during the study period 10. Subject who agrees not to carry out bleaching or any other procedures including facial etc. on face during the study period 11. Subject who agrees to remove all jewellery on/around face (e.g., necklace, earrings, nose ring), during VISIA imaging 12. Female subject with child-bearing potential willing to undergo Urine Pregnancy Test and to use acceptable methods of contraception 13. Subjects who are able to give written informed consent and to comply with the requirements of the study 14. Subjects who are ready to follow instructions and study restrictions during the study period
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any of the study products or constituents 2. Any significant skin pathology in the test area, like rosacea, severe acne, or eczema 3. Subjects on any topical or systemic treatment that could interfere with the study treatments/assessments (topical benzoyl peroxide and other anti-acne or anti-seborreic products, antibiotics, corticosteroids, retinoids, anti-inflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study 4. Subjects who are having chronic illness or had major surgery in the last year 5. Subject with any significant medical condition that would interfere with the participation in the trial 6. Subject who are allergic or sensitive to bar cleansing products/face cleansers/ creams/lotions, artificial jewellery or anything else 7. Females in pregnancy or lactation at the beginning of the study or planned during the study 8. Subject reported or planning to sun-bathe or to overexpose to UV-light (mountain, sports, phototherapy, tanning salon useâ?¦) for aesthetic or therapeutic reasons the month before the study start or during the study 9. Participation in any other clinical trial up to 1 month prior to screening and during the study 10. Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids, vitamins , etc. that, in the investigatorâ??s judgement, could interfere with the study treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the study 11. Subjects Who have started, stopped or changed their hormonal treatment(s) (including contraceptive pill) in the previous one month prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the acne lesion count, clinical scoring for oily touch, shiny aspect,tactile roughness, skin radiance, density and contrast of pigmentary spot, cheek sebaceous pores, dryness and redness, measurement of sebum casual levels and sebum excretion rate, skin pH, measurement of skin hydration, measurement of trans-epidermal water loss, size of an isolated spot, intensity of isolated spot and skin colorTimepoint: Day 7, Day 14, Day 21, Day 28, Day 35 compared to Day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard imaging using VISIA-CR Subjective Evaluation questionnaire answered by the subjects Changes in all parameters mentioned in primary criteria occurring during the wash-out phase from Day -7 to Day 0 would be compared to the changes occurring from Day 0 to Day 7 Safety assessment by the total number of adverse events & local intolerances reported throughout the studyTimepoint: Day 7, Day 14, Day 21, Day 28, and Day 35 as compared to Day 0 | — |
Countries
India
Contacts
Public ContactRajat Gupta
CIDP Biotech India Pvt. Ltd
Outcome results
None listed