evaluation of the efficacy of a dietary supplement on hair loss and hair aspect

Conditions: Healthy Volunteers

Summary: the study is aimed to assess the efficacy of a dietary supplement composed of a wheat polar lipid complex (wplc) in reducing hair loss and improving hair aspect.

a double blind, parallel groups, placebo-controlled study is carried out on 60 healthy female subjects aged between 18 and 65 years old with all hair type showing diffuse and temporary hair shedding with a proportion of hair in telogen phase \>15%. the study foresees 84 days of products intake. evaluations of the parameters under study are performed at baseline, after 56 and 84 days of products consumption.

Eligibility criteria:
inclusion criteria : * healthy female subjects, * caucasian ethnicity, * age between 18 and 65 years old, * all hair type included, * women showing a proportion of hair in telogen phase \> 15%, * subjects complaining brittle and thin hair, * subjects who stopped any anti hair loss treatment at least 3 months prior the study, * 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, * subjects who have not been involved in any other similar in the last 3 months, * subjects registered with health social security or health social insurance, * subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial, * subjects able to understand the language used in the investigation center and the information given, * subjects able to comply with the protocol and follow protocol's constraints and specific requirements, * willingness to use the same products for hair care during all the study period, * willingness not to cut hair for all the study length, * subjects having signed their written informed consent form (icf) for their participation in the study and a photograph authorization. exclusion criteria: * subject does not meet the inclusion criteria, * subject is taking part or planning to participate to another clinical study in the same or in another investigation centre, * subject is deprived of freedom by administrative or legal decision or under guardianship, * subject is admitted in a sanitary or social facilities, * subject is planning an hospitalization during the study, * subject has participated in another clinical study with anti-hair loss product or treatment within the last 24 weeks before the inclusion visit, * subject is breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential), * subject has started or changed oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study, * subject 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, * subject is in course of a long-treatment or intending to have one considered by the investigator liable to interfere with the study data or incompatible with the study requirements, * subject having a skin/scalp condition liable to interfere with the study data or considered by the investigator hazardous for the subject or incompatible with the study requirements, * subject having personal history of cosmetic, drug, domestic products or food supplements allergy, * subject having food disorders, * subject who has any other hair disorder or hair disease (female pattern hair loss, any type of alopecia...), * subject having excessive and/or fluctuating hair shedding for more than 6 months, * history or clinical signs of hyperandrogenemia (menstrual cycle \>35 days and hirsutism and acne), * systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit: retinoids, anti-mitotic, cytotoxic drugs other than antineoplastic, anti-androgens (spironolactone, flutamide), androgens, anti-epileptic agents, interferon alpha, * systemic or local androgenetic alopecia treatment or product, taken or applied (minoxidil, aminexil, finasteride, dutasteride, cosmetic solution or capsules with vitamin b, zinc, caffeine...) for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit, * any other topical treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole...) within the last 2 weeks before the inclusion visit, * no hair wash in the 48 hours before each visit, * any following hair care within the last 2 weeks before each visit: dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm, * any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam...), * radiotherapy, chemotherapy at any time, * scalp surgery (hair transplants, laser) at any time