Acne Skin and Connective Tissue Diseases
Conditions
Interventions
Active and placebo food supplement are manufactured according to the applicable national and international rules and regulation. All ingredients included in the active and placebo formula are approved
Sponsors
SYNBALANCE SRL
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Asian female subjects 2. Aged between 18 and 45 (extremes included) years old 3. Subjects showing acne severity from 1 to 3 according to IGA scale 4. Subjects who have not been recently involved in any other similar study 5. Willingness to use during all the study period only the product to be tested 6. Subjects certifying the truthfulness of the personal data disclosed to the investigator 7. Subjects able to understand the language used in the investigation center and the information given by the investigator 8. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 9. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study 10. Commitment not to change the daily routine or the lifestyle 11. Subjects having signed their written Informed Consent form (ICF) and privacy form for their participation in the study and a photograph authorization.
Exclusion criteria
Exclusion criteria: 1. Subjects who do not fit the inclusion criteria; 2. Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements; 3. Subjects participating or planning to participate in other clinical trials; 4. Subjects deprived of freedom by administrative or legal decision or under guardianship; 5. Subjects not able to be contacted in case of emergency; 6. Subjects admitted to a health or social facility; 7. Subjects planning a hospitalisation during the study; 8. Subjects who participated in a similar study without respecting an adequate washout period; 9. Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements; 10. Subjects with known hypersensitivity or allergy to one of the active ingredients; 11. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator as for example medication with photosensitizing potential, drugs specific for acne treatment as isotretinoin or antibiotics, and/or food supplements and specific local therapy for acne treatment, currently or during the month before the study start; 12. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements; 13. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices; 14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential); 15. Consumption of food supplement(s) containing probiotic and/or for skin/hair/nail care currently or within the past 12 weeks before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Numbers of acne lesions (papules, pustules, open and closed comedones) at baseline (T0), after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). 2. Skin sebum content measured using Sebumeter 815 Courage+Khazaka GmbH, at baseline (T0), after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). 3. Skin moisturization measured using Corneometer CM825 Courage+Khazaka GmbH, at baseline (T0), after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). 4. Skin pH measured using SKIN pH-meter® 905 Courage+Khazaka GmbH, at baseline (T0), after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). 5. Digital pictures acquired by means of Visia®-CR (Canfield Scientific). at baseline (T0), after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). 6. Clinical evaluation of the improvment of skin complexion evenness (internal clinical scale) after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). 7. Clinical evaluation of the improvment of the erythemal state of the area interested by acne inflammatory lesions (internal clinical scale) after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (“The Cardiff Acne Disability Index”) at baseline (T0), after 28 days (T28) and 56 days (T56) of product intake and after 14 days of follow-up (T70). 2. Product acceptability and volunteers’ perceived efficacy assessed with a self-assessment questionnaire at T56 and T70. 3. Product tolerability for all the study length assessed with a self-assessment questionnaire at T70 | — |
Countries
China
Contacts
Public ContactIleana De Ponti
Outcome results
None listed