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

Double-blind, Randomized, Placebo-controlled Clinical-instrumental Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-hair Loss Properties and Hair Aspect Improvement

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Wheat Polar Lipid Complex; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20024
    • Complife Italia srl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wheat Polar Lipid Complex; Dietary supplement - Wheat Polar Lipid Complex	Dietary supplement: Wheat Polar Lipid Complex; The study foresees the intake of 2 capsules per day during 84 days
Placebo Comparator: Placebo; Dietary supplement - Placebo	Dietary supplement: Placebo; The study foresees the intake of 2 capsules per day during 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telogen hair proportion	Phototrichogram	Baseline
Telogen hair proportion	Phototrichogram	56 days
Telogen hair proportion	Phototrichogram	84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anagen hair proportion	Phototrichogram	Baseline
Anagen hair proportion	Phototrichogram	56 days
Anagen hair proportion	Phototrichogram	84 days
Hair growth	Hair length after shaving	84 days
Hair elasticity	Hair elongation using dynamometer	Baseline
Hair elasticity	Hair elongation using dynamometer	84 days
Scalp sebum content	Sebumeter	Baseline
Scalp sebum content	Sebumeter	56 days
Scalp sebum content	Sebumeter	84 days
Hair diameter	Optical microscopy	Baseline
Hair diameter	Optical microscopy	84 days
Hair loss	Pull test	Baseline
Hair loss	Pull test	56 days
Hair loss	Pull test	84 days
Hair density	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)	Baseline
Hair density	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)	56 days
Hair density	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)	84 days
Hair volume	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)	Baseline
Hair volume	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)	56 days
Hair volume	Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)	84 days
Self-assessment of product efficacy	Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)	84 days

Collaborators and Investigators

• Sponsor: Seppic
• Investigators: Study Director: Ileana De Ponti, Complife Italia S.r.l

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: IT0003492/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No