Evaluation of the Efficacy of Two Dietary Supplements on Hair Loss and Hair Aspect

Seppic

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Wheat Polar Lipid Complex Powder; Dietary Supplement: Wheat Polar Lipid Complex Oil; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06028295

IT0003622/23

Details and patient eligibility

About

The study is aimed to assess the efficacy of two dietary supplements composed of a Wheat Polar Lipid Complex (WPLC) in oil or powder form in reducing hair loss and improving hair aspect.

Full description

A double blind, parallel groups, placebo-controlled study is carried out on 90 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: 99 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 (extremes included),
• All hair type included,
• Subject showing acute hair shedding (duration less than 6 months) due to fatigue, seasonal change, deficiency of vitamins and minerals, stress, change or imbalance of normal daily routing, or emotional stress,
• 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 study in the last 3 months,
• Subjects registered with health social security or health social insurance, 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 3 months 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

Wheat Polar Lipid Complex Oil

Experimental group

Description:

Dietary supplement - Wheat Polar Lipid Complex (Oil)

Treatment:

Dietary Supplement: Wheat Polar Lipid Complex Oil

Wheat Polar Lipid Complex Powder

Experimental group

Description:

Dietary supplement - Wheat Polar Lipid Complex (Powder)

Treatment:

Dietary Supplement: Wheat Polar Lipid Complex Powder

Placebo

Placebo Comparator group

Description:

Dietary supplement - Placebo

Treatment:

Dietary Supplement: Placebo