L70.0
Conditions
Interventions
Group 1: - 30 subjects applied a formulation with living bacteria for 16 weeks
- visits are at day 1, 7, 28, 56, 84, 91, 98
Subjects’ skin will be evaluated by the investigator (dermatologist) on:
-
Sponsors
Universitätshautklinik
Eligibility
Sex/Gender
All
Age
16 Years to 23 Years
Inclusion criteria
Inclusion criteria: - Healthy female and male subjects, - Age 16 – 23 years - Subjects with an acne prone skin and lesions up to grade 4 according to the Leeds scale. - Subjects free of anti-acneic or antiseborrheic topical medical treatment, for at least 2 weeks before the beginning of the study. - Subjects free of topic retinoid treatment, for at least 2 weeks before the beginning of the study. - Subjects free of oral retinoid therapy for at least 2 months before the beginning of the study. - Subjects free of topic and oral antibiotic treatment for at least 4 weeks before the beginning of the study. - Subjects willing to cooperate and participate by following requirements for the duration of the study: • To use only the provided products on the face in replacement of their usual face skin care products; • To use make-up products only for lips and eyes; • Not to manipulate with the lesions face (press, try to efface, etc.); • Not to use any exfoliating products on the face; - Subjects willing to report immediately any adverse symptoms. - Subjects able to read understand and provide written informed consent. - Subjects having a stable means of contraception for at least 3 months before beginning of the study and not changing the means of contraception during the study. - Subjects are willing to skip swimming in water with chlorine
Exclusion criteria
Exclusion criteria: - Subjects unable to follow the requirements of the protocol. - Subjects planning or undergoing another clinical study. - Subjects presenting severe inflammatory lesions, above grade 4 Leeds score. - Subjects presenting irritated or damaged skin on the whole face (area with desquamation, dryness, skin picking etc.). - Subjects performing themselves aesthetic cares (scrub, etc.), aesthetic care by a beautician (deep skin cleansing) or undergoing aesthetic acts performed by the Dermatologist (dermabrasion, peeling, laser, etc.) during the study period and at least 2 months before the study begins. - Subjects having any disease or skin condition that the examining investigator seems inappropriate for participation. - Subjects having active or localized or systemic infection. - Subjects with atopic skin diseases (atopic dermatitis, eczema, etc…) other than seasonal allergies. - Subject stopping topical acne drugs for less than 2 weeks - Subject stopping systemic cyclines for less than 1 month - Subject under isotretinoin - Subjects using / applying vitamin B complex - Women under oral contraception for less than 3 months before the beginning of the study or planning to modify their contraception treatment within the duration of the study. - Women having antiandrogenic hormonal treatment (cyproterone acetate, CMA and others) for less than 3 months before the beginning of the study. - Women known to be pregnant, nursing or planning to become pregnant within 6 months. - Male with lot of facial hair und full beard - Subjects currently taking prescriptions medications (e.g. oral or topical steroids, anti-inflammatory drugs) or applying either topical prescriptions drugs and/or over-the-counter (OTC) skin treatments on the face. - Subjects not willing to be photographed. - Subjects with a known allergy or hypersensitivity to one of the constituents of the provided products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to establish a useful, stable and balanced skin microbiome. Subjects’ skin will be evaluated by the investigator (dermatologist) on: - Status of the acne prone skin by lesion count and imaging (photographic documentation) - Irritation, redness and other adverse reactions (desquamation, itching, deterioration) - Microbiome composition by a strip sample (3-S-Biokit) and a swab sample (sterile swabs) – both non-invasive - Sebaceous lipid analysis using sebutape and a sebumeter – both non-invasive - pH values using pH meter – non-invasive | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Analysis of the stability and responder rate to ensure the safety and general compatibility of the modulating facial acne microbiome with living beneficial bacteria 2. Observation of the development of the microbial millieu on facial acne skin | — |
Countries
Germany
Contacts
Public ContactAnte Karoglan
Universitätshautklinik
Outcome results
None listed