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

Primary Purpose

Healthy Volunteers

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Wheat Polar Lipid Complex Oil
Wheat Polar Lipid Complex Powder
Placebo
Sponsored by
Seppic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Complife Italia srlRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Wheat Polar Lipid Complex Oil

Wheat Polar Lipid Complex Powder

Placebo

Arm Description

Dietary supplement - Wheat Polar Lipid Complex (Oil)

Dietary supplement - Wheat Polar Lipid Complex (Powder)

Dietary supplement - Placebo

Outcomes

Primary Outcome Measures

Telogen hair proportion
Phototrichogram
Telogen hair proportion
Phototrichogram
Telogen hair proportion
Phototrichogram

Secondary Outcome Measures

Anagen hair proportion
Phototrichogram
Anagen hair proportion
Phototrichogram
Anagen hair proportion
Phototrichogram
Hair growth
Hair length after shaving
Hair elasticity
Hair elongation using dynamometer
Hair elasticity
Hair elongation using dynamometer
Hair loss
Pull test
Hair loss
Pull test
Hair loss
Pull test
Self-assessment of product efficacy
Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)

Full Information

First Posted
August 31, 2023
Last Updated
October 10, 2023
Sponsor
Seppic
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1. Study Identification

Unique Protocol Identification Number
NCT06028295
Brief Title
Evaluation of the Efficacy of Two Dietary Supplements on Hair Loss and Hair Aspect
Official Title
Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-hair Loss Properties and Hair Strength Improvement. A Double-blind, Randomized, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seppic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wheat Polar Lipid Complex Oil
Arm Type
Experimental
Arm Description
Dietary supplement - Wheat Polar Lipid Complex (Oil)
Arm Title
Wheat Polar Lipid Complex Powder
Arm Type
Experimental
Arm Description
Dietary supplement - Wheat Polar Lipid Complex (Powder)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary supplement - Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Wheat Polar Lipid Complex Oil
Intervention Description
The study foresees the intake of 2 capsules per day during 84 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Wheat Polar Lipid Complex Powder
Intervention Description
The study foresees the intake of 2 capsules per day during 84 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The study foresees the intake of 2 capsules per day during 84 days
Primary Outcome Measure Information:
Title
Telogen hair proportion
Description
Phototrichogram
Time Frame
Baseline
Title
Telogen hair proportion
Description
Phototrichogram
Time Frame
56 days
Title
Telogen hair proportion
Description
Phototrichogram
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Anagen hair proportion
Description
Phototrichogram
Time Frame
Baseline
Title
Anagen hair proportion
Description
Phototrichogram
Time Frame
56 days
Title
Anagen hair proportion
Description
Phototrichogram
Time Frame
84 days
Title
Hair growth
Description
Hair length after shaving
Time Frame
84 days
Title
Hair elasticity
Description
Hair elongation using dynamometer
Time Frame
Baseline
Title
Hair elasticity
Description
Hair elongation using dynamometer
Time Frame
84 days
Title
Hair loss
Description
Pull test
Time Frame
Baseline
Title
Hair loss
Description
Pull test
Time Frame
56 days
Title
Hair loss
Description
Pull test
Time Frame
84 days
Title
Self-assessment of product efficacy
Description
Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Time Frame
84 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Dudonné
Phone
+ 33 563726744
Email
stephanie.dudonne@airliquide.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ileana De Ponti
Organizational Affiliation
Complife Italia S.r.l
Official's Role
Study Director
Facility Information:
Facility Name
Complife Italia srl
City
Milano
ZIP/Postal Code
20024
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ileana De Ponti
Phone
+39 382490286
Email
ileana.deponti@complifegroup.com

12. IPD Sharing Statement

Learn more about this trial

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

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