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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Wheat Polar Lipid Complex

• Registration Number: NCT05954039
• Lead Sponsor: Seppic

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-09-07
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2023-07
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dietary supplement - Placebo
Wheat Polar Lipid Complex	Wheat Polar Lipid Complex	Dietary supplement - Wheat Polar Lipid Complex

Primary Outcome Measures

Name	Time	Method
Telogen hair proportion	84 days	Phototrichogram

Secondary Outcome Measures

Name	Time	Method
Hair volume	84 days	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)
Hair loss	84 days	Pull test
Hair growth	84 days	Hair length after shaving
Hair elasticity	84 days	Hair elongation using dynamometer
Scalp sebum content	84 days	Sebumeter
Hair diameter	84 days	Optical microscopy
Hair density	84 days	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)
Anagen hair proportion	84 days	Phototrichogram
Self-assessment of product efficacy	84 days	Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)

Trial Locations

Locations (1)

Complife Italia srl; 🇮🇹 Milano, Italy