None listed
Conditions
Interventions
Intervention1: POC Trio Microbiome
Cmax 3,2% PHYLOBACIL
0,8% ACCUBIOME: Participants will apply 2 pumps of the face cream to the entire face twice daily for 56 days.
Intervention2: POC Trio Microbiom
Sponsors
L OREAL SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female volunteer from 18 to 40 years old. 2. Phototype 3 to 5 according to the Fitzpatrick classification. 3. Female of non-childbearing potential who is surgically sterile or female of childbearing potential, who is using an effective non androgenic contraceptive method for at least 12 weeks before the beginning of the study, and throughout the study. 4. Female of childbearing potential willing to undergo urine pregnancy test. 5. Female having a regular menstrual period between 21 to 35 days and declaring to have no acne breakouts around menstruation. 6. Presenting moderate (grade 3) to severe (grade 4) acne severity on a GEA scale from 0 to 5, according to the Investigator point of view. 7. Presenting acne lesions count (excluding the nasal pyramid, the vermillion border, the crease of the chin and the rim of the scalp) greater than and equal to 6 inflammatory acne lesions on each side of the face.
Exclusion criteria
Exclusion criteria: 1. Volunteer who is pregnant or lactating or who is planning to become pregnant during the study 2. Menopausal female with absence of menstruation for less than one year or post menopausal female with absence of menstruation for more than one year 3. Any change in hormonal treatment within the last 3 months or planning to change hormonal treatment during the study 4. Volunteer under treatment with thyroid hormones 5. Body Mass Index BMI greater than 32 6. History of skin cancer 7. History of allergies hypersensitivity or any serious reactions to any cosmetic products 8. Having used within the past 8 weeks before screening for more than 3 consecutive days any systemic or topical drugs related to antibiotics anti inflammatory drugs corticoids topical retinoids or any anti acne or anti seborrheic products or planning to use these treatments during the study 9. Having used oral Isotretinoin treatment during adolescence or adulthood 10. Having used within the last month before screening any depigmenting whitening or pro pigmenting including self tanning topical treatments or planning to use these treatments during the study on the face 11. Having used within the past 6 months any physical treatment including laser phototherapy PUVA IPL PDT Botox or fillers such as hyaluronic acid on the investigational sites or planning to use these treatments during the study 12. Having used any anti acne or anti seborrheic topical cosmetic products for at least 15 days before the screening visit or planning to use these products during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C. acnes phylotypes distribution by SLST analysis from microbiome sampling on cheekTimepoint: D0, D7, D28 and D56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quantification of total bacteria load and load of C. acnes, Malassezia total and Staphylococcus aureus by qPCR analyses from microbiome sampling on cheek. 2. Acne grade scoring (GEA) by a trained dermatologist 3. Inflammatory and non-inflammatory lesions count on whole face 4. Clinical scores of skin shininess 5. Oily touch by a dermatologist 6. Skin redness 7. Sebum quantity using Sebumeter CLTimepoint: D0, D7, D28 and D56 | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed