Healthy volunteers with acne prone skin Skin and Connective Tissue Diseases
Conditions
Interventions
The active intervention is a food supplement based on Berberine Phytosome™ (Berberine Phospholipids), standardized with a content of Berberine ranging from 28% to 34%
while the placebo intervention is composed exclusively of inert excipients and coating agents. Both the active and the placebo products are used as follows: the first group of subjects will take two t
Sponsors
INDENA S.P.A.
Eligibility
Sex/Gender
All
Age
18 Years to 25 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/04/2026: 1. Good general health 2. Caucasian ethnicity 3. Female or male sex 4. Age between 18 and 25 years old (subject with 18 and 25 years old can be included) 5. Subjects with acne prone skin, showing light to moderate acne prone skin with non-inflammatory lesions (comedones) and light inflammatory lesions (papules and pustules) 6. Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the Investigator but at least 1 month must be elapsed between a previous study on food supplement) 7. Subjects registered with health social security or health social insurance 8. Subjects having signed their written the Informed Consent Form (ICF) and Privacy Policy for their participation in the study and a photograph authorization 9. Subjects able to understand the language used in the investigation centre and the information given 10. Subjects able to comply with the protocol and follow protocol constraints and specific requirements 11. Willingness to use during all the study period only the product to be tested 12. Willingness not to use similar products that could interfere with the product to be tested (e.g. products with anti-acne efficacy)* 13. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.) 14. Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial * During the whole study period, subjects will use a defined cosmetic routine for face care, defined by the Costumer. Previous inclusion criteria: 1. Good general health 2. Caucasian ethnicity 3. Female sex 4. Age between 18 and 25 years old (subject with 18 and 25 years old can be included) 5. Subjects with acne prone skin, showing light to moderate acne prone skin with non-inflammatory lesions (comedones) and light inflammatory lesions (papules and pustules) 6. Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the Investigator but at least 1 month must be elapsed between a previous study on food supplement) 7. Subjects registered with health social security or health social insurance 8. Subjects having signed their written the Informed Consent Form (ICF) and Privacy Policy for their participation in the study and a photograph authorization 9. Subjects able to understand the language used in the investigation centre and the information given 10. Subjects able to comply with the protocol and follow protocol constraints and specific requirements 11. Willingness to use during all the study period only the product to be tested 12. Willingness not to use similar products that could interfere with the product to be tested (e.g. products with anti-acne efficacy)* 13. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.) 14. Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial * During the whole study period, subjects will use a defined cosmetic routine for face care, defined by the Costumer.
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subject is taking part or planning to participate to another clinical study in the same or in another investigation centre 3. Subject who is deprived of freedom by administrative or legal decision or under guardianship 4. Subject admitted in a sanitary or social facilities 5. Subject who is planning an hospitalization during the study 6. Subjects under treatment with food supplements which could interfere with the functionality of the product under study 7. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential) 8. Subject has started or changed estrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study 9. Subject having an acute, chronic or progressive diseases (e.g severe atopic dermatitis, psoriasis) liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 10. Subjects under radiotherapy, chemotherapy at any time 11. Subject having a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 12. Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology (e.g. topical retinoids, topical antibiotics, oral antibiotics, isotretinoin) 13. Subjects under locally pharmacological/non-pharmacological treatment applied on the skin area monitored during the test (e.g. topical retinoids, topical antibiotics, isotretinoin) 14. Subject with known or suspected sensitization to one or more test formulation ingredients 15. Subjects considered as not adequate to participate to the study by the investigator 16. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated) 17. Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improve of the acne severity measured using the Investigator’s Global Assessment (IGA) scale, a standardized 5-point system that rates the skin based on the number and type of acne lesions (blackheads, papules, pustules, and nodules) at baseline and after 28, 56 and 84 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the number of non-inflammatory and inflammatory lesions measured using skin counting the acneic lesions at baseline and after 28, 56 and 84 days.;Digital macrophotography measured using Visia®-CR (Canfield Scientific) at baseline and after 28, 56 and 84 days.;Personal opinion on the tested product measured using self-assessment questionnaire at 28, 56 and 84 days.;Quality of life measured using quality of life questionnaire at baseline and after 28, 56 and 84 days.;Transepidermal water loss measured using Tewameter 300® (Courage+Khazaka, electronic GmbH) at baseline and after 28, 56 and 84 days.;Skin sebum content measured using Sebumeter® method (Sebumeter 815, Courage+Khazaka GmbH) at baseline and after 28, 56 and 84 days.;Skin redness (a* parameter) measured using dedicated software for image analysis (Image J) at baseline and after 28, 56 and 84 days.;Skin profilometry – Sa parameter related to skin smoothness in the cheek area measured using Primos CR-SF (Canfield Scientific) 3D imaging (fringe projection) at baseline and after 28, 56 and 84 days.;Skin moisturization measured using Corneometer® method at baseline and after 28, 56 and 84 days. | — |
Countries
Italy
Contacts
Public ContactAnna Pelizzola
Outcome results
None listed