L70.0 L70
Conditions
Interventions
Group 1: Half of the subject receive a topical formulation containing 2 bacterial strains
Group 2: Half of the subject receive a topical formulation containing 4 bacterial strains
Sponsors
Universitätshautklinik
Eligibility
Sex/Gender
All
Age
18 Years to 23 Years
Inclusion criteria
Inclusion criteria: Healthy female and male volunteers, - Age 16 - 23 years - Subjects with skin prone to acne and lesions up to grade 4 on the Leeds scale. - Subjects who are free of anti-acne or antiseborrheic topical medical treatments until at least 2 weeks before the start of the study. - subjects without topical retinoid treatment, for at least 2 weeks before the start of the study - subjects who did not receive oral retinoid therapy for at least two months prior to the start of the study - subjects without topical and oral antibiotic treatment for at least 4 weeks prior to the start of the study - Subjects who are willing to cooperate and comply with the following requirements for the duration of the study: - Use only the products provided on the face to replace their usual facial care products; - Use make-up products for lips and eyes only. - Do not manipulate the lesions (press, try to soft, etc.) - Do not use peeling products on the face - Subjects who are willing to report unwanted symptoms immediately - Test persons who are able to read, understand and consent in writing - subjects with constant contraception for at least 3 months before the start of the study and no planned change during the study - test persons who are willing to refrain from swimming in chlorinated water
Exclusion criteria
Exclusion criteria: - Subjects who cannot follow the requirements of the protocol - Subjects planning to participate in another study or participating in one - subjects with severe inflammatory lesions, greater than Grade 4 of the Leeds Score - subjects who have skin irritations or damages in the whole face (area with desquamation, dryness, skin picking etc.) - Subjects who treat themselves aesthetically (peeling, etc.), aesthetic care by a cosmetician (deep skin cleansing) or aesthetic treatments by a dermatologist (dermabrasion, peeling, laser, etc.) during the study period and at least 2 months before the start of the study. - Test persons who have a disease or skin disease which, in the doctor's opinion, excludes participation - subjects with active or localized or systemic infection - volunteers with atopic skin diseases (atopic dermatitis, eczema, etc ...) except seasonal allergies - subjects under topical treatment with acne medication within the last 2 weeks - volunteers, under systemic treatment with cyclins intrahlb of the last month - subjects under isotretinoin treatment - Probands with vitamin B complex intake - Women with oral contraception within the last 3 months before the start of the study or who plan to change their contraception within the duration of the study. - women undergoing anti-androgen hormonal treatment (cyproterone acetate, CMA and others) within the last 3 months before the start of the study - Women who are pregnant, breastfeeding or planning to become pregnant within 6 months. - Men with a lot of facial hair and a full beard subjects currently taking medication (e.g., oral or topical steroids, anti-inflammatory drugs) or either topical prescription drugs and / or over-the-counter (OTC) facial skin treatments - Subjects who do not want to be photographed subjects with a known allergy or hypersensitivity to any of the components of the test product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of an establishment of a useful, stable and balanced skin microbiome is to be determined. The skin of the test persons is examined by the physician (dermatologist) with regard to: - Acne status of the skin by lesion counting and imaging (photographic documentation) - irritation, redness, and other side effects (squamation, itching, worsening) - Microbial composition by a stripe sample (3-S-biokit) and a swab sample (sterile swab) - both non-invasive - Sebaceous lipid analysis with sebutape and a sebumeter - both are non-invasive - pH-value of the skin with pH-meter - non-invasive | — |
Secondary
| Measure | Time frame |
|---|---|
| Observation of the development of microbial millieus on facial acne skin | — |
Countries
Germany
Contacts
Public ContactAnte Karoglan
Universitätshautklinik
Outcome results
None listed