Effectiveness of a food supplement on hair loss

INTERVENTION: The test product is manufactured according to the applicable national and international rules and regulations. All ingredients included in the product formula are approved for their use in food/food supplements. The study foresees 84 days of product consumption. Evaluations of the parameters under study are performed at baseline (T0), after 28 (T28) and 84 days (T84) of product intake. According to a previously defined randomization list subjects are divided into three homogenous study groups as follows: 24 subjects take the first dose of the active food supplement 24 subjects take the second dose of active food supplement 24 subjects take the placebo food supplement Each group will include: 12 Caucasian volunteers recruited in Italy of which 6 are female and 6 are male 12 Chinese volunteers recruited in China of which 6 are female and 6 are male For group who take first dose of active food supplement and the placebo food supplement, the study foresees the intake of one capsule per day in the morning on empty stomach, between meals, with a glass of still water for the 84 days of treatment while for group who take second dose of active food supplement, the study foresees the intake of two capsules per day in the morning on an empty stomach, between meals, with a glass of still water for the 84 days of treatment. 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 seale CONDITION: Acute telogen effluvium from less than 6 months (presenting =15% of telogen parameter at inclusion), with a hair length of at least 5 cm, complaining of brittle and thin hair ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: 1. Phototrichogram (total hair density [number of total hairs per cm²], telogen hair density [number of hairs in telogen phase per cm²] and proportion [%], anagen hair density [number of hairs in anagen phase per cm²] and proportion [%], hair thickness) measured using TrichoScan® at baseline (T0), 28 days (T28), T84 days (T84); 2. Hair elasticity (maximum elongation before hair breakage) in Caucasian subjects measured using a dynamometer (Tensolab 2512A, Mesdan Lab.) at baseline (T0) and at T84 days (T84); 3. Hair brightness measured using the spectrophotometer/colorimeter CM‐700D (Konica‐Minolta) at baseline (T0) and at T84 days (T84); 4. Digital pictures acquired using a digital camera at baseline (T0), 28 days (T28) and 84 days (T84) SECONDARY OUTCOME: 1. Product safety assessed using adverse events recording throughout the study (T28 and T84); 2. Product acceptability and volunteers’ perceived efficacy assessed with a self‐assessment questionnaire at T84 INCLUSION CRITERIA: 1. Healthy female (50%) and male (50%) subjects 2. Multi‐ethnic panel (50% Asian and 50% Caucasian ethnicity) 3. Aged between 18 and 65 (extremes included) years old 4. All hair types included 5. Subjects showing acute telogen effluvium from less than 6 months (due to fatigue/stress/deficient diet/post‐partum/hormonal/fever, etc) 6. Subjects presenting > 15% of telogen parameter at inclusion 7. Subjects with a hair length of at least 5 cm 8. Subjects complaining of brittle and thin hair 9. Subjects who stopped any anti hair loss treatment at least 3 months prior to the study 10. Subjects agreeing not to take any treatment (oral or topic) able to interfere with the hair growth, diameter or fall during the whole study duration 11. Subjects registered with health social security or health social insurance 12. Subjects able to understand the language used in the investigation center and the information given 13. Subjects able to compl