Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect

Seppic

Status

Completed

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Wheat Polar Lipid Complex

Study type

Interventional

Funder types

Industry

Identifiers

NCT05954039

IT0003492/22

Details and patient eligibility

About

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.

Full description

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.

Enrollment

66 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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