Effectiveness of a food supplement on acne prone skin on Asian population

INTERVENTION: 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 for their use in food/food supplements. All the active and the placebo products are used as follows: 1 capsule per day, preferably far from meal, for 56 days. All participants will apply for all the study length a base cream with no cosmetic claim for face care, two times a day (morning and evening). Participants are randomly into two groups of 32 subjects as follows: 1. 30 subjects (32 included) take the active study product 2. 30 subjects (32 included) take the placebo formulation A restricted randomization list is created using PASS 2008 (PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64‐bit Edition (Microsoft, USA) by a biostatistician and stored in a safe place. The randomization sequence was stratified using “Efron’s biased coin” algorithm with a 1:1 allocation ratio. The allocation sequence was concealed from the in‐site study director in sequentially numbered, opaque and sealed envelopes, reporting the unblinded treatment allocation (based on the subject entry number in the study). The A4 sheet reporting the unblinded treatment was folded to render the envelope impermeable to intense light. A masked allocation sequence was prepared for the staff delivering the intervention based on the subject entry number in the study. CONDITION: Acne ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: ; 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 OUTCOME: ; 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; 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 dail