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

NCT ID: NCT06028295

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2023-12-21

Brief Summary

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.

Detailed 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Wheat Polar Lipid Complex Oil

Dietary supplement - Wheat Polar Lipid Complex (Oil)

Group Type: EXPERIMENTAL

Wheat Polar Lipid Complex Oil

Intervention Type: DIETARY_SUPPLEMENT

The study foresees the intake of 2 capsules per day during 84 days

Wheat Polar Lipid Complex Powder

Dietary supplement - Wheat Polar Lipid Complex (Powder)

Group Type: EXPERIMENTAL

Wheat Polar Lipid Complex Powder

Intervention Type: DIETARY_SUPPLEMENT

The study foresees the intake of 2 capsules per day during 84 days

Placebo

Dietary supplement - Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The study foresees the intake of 2 capsules per day during 84 days

Interventions

Wheat Polar Lipid Complex Oil

The study foresees the intake of 2 capsules per day during 84 days

Intervention Type: DIETARY_SUPPLEMENT

Wheat Polar Lipid Complex Powder

The study foresees the intake of 2 capsules per day during 84 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The study foresees the intake of 2 capsules per day during 84 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seppic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ileana De Ponti

Role: STUDY_DIRECTOR

Complife Italia S.r.l

Locations

Complife Italia srl

Milan, , Italy

Countries

Italy

Other Identifiers

IT0003622/23

Identifier Type: -

Identifier Source: org_study_id