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

• ClinicalTrials.gov Identifier: NCT05954039
• Recruitment Status: Completed
• First Posted: July 20, 2023
• Last Update Posted: July 20, 2023
• Sponsor: Seppic
• Information provided by (Responsible Party): Seppic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Dietary Supplement: Wheat Polar Lipid Complex; Dietary Supplement: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-blind, Randomized, Placebo-controlled Clinical-instrumental Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-hair Loss Properties and Hair Aspect Improvement
• Actual Study Start Date: September 7, 2022
• Actual Primary Completion Date: December 23, 2022
• Actual Study Completion Date: December 23, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Telogen hair proportion [ Time Frame: Baseline ]
   Phototrichogram
2. Telogen hair proportion [ Time Frame: 56 days ]
   Phototrichogram
3. Telogen hair proportion [ Time Frame: 84 days ]
   Phototrichogram

Secondary Outcome Measures :

1. Anagen hair proportion [ Time Frame: Baseline ]
   Phototrichogram
2. Anagen hair proportion [ Time Frame: 56 days ]
   Phototrichogram
3. Anagen hair proportion [ Time Frame: 84 days ]
   Phototrichogram
4. Hair growth [ Time Frame: 84 days ]
   Hair length after shaving
5. Hair elasticity [ Time Frame: Baseline ]
   Hair elongation using dynamometer
6. Hair elasticity [ Time Frame: 84 days ]
   Hair elongation using dynamometer
7. Scalp sebum content [ Time Frame: Baseline ]
   Sebumeter
8. Scalp sebum content [ Time Frame: 56 days ]
   Sebumeter
9. Scalp sebum content [ Time Frame: 84 days ]
   Sebumeter
10. Hair diameter [ Time Frame: Baseline ]
    Optical microscopy
11. Hair diameter [ Time Frame: 84 days ]
    Optical microscopy
12. Hair loss [ Time Frame: Baseline ]
    Pull test
13. Hair loss [ Time Frame: 56 days ]
    Pull test
14. Hair loss [ Time Frame: 84 days ]
    Pull test
15. Hair density [ Time Frame: Baseline ]
    Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)
16. Hair density [ Time Frame: 56 days ]
    Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)
17. Hair density [ Time Frame: 84 days ]
    Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)
18. Hair volume [ Time Frame: Baseline ]
    Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)
19. Hair volume [ Time Frame: 56 days ]
    Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)
20. Hair volume [ Time Frame: 84 days ]
    Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)
21. Self-assessment of product efficacy [ Time Frame: 84 days ]
    Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Italy

Complife Italia srl

Milano, Italy, 20024

Sponsors and Collaborators

Seppic

Investigators

• Study Director: Ileana De Ponti; Complife Italia S.r.l

More Information

• Responsible Party: Seppic
• ClinicalTrials.gov Identifier: NCT05954039
• Other Study ID Numbers: IT0003492/22
• First Posted: July 20, 2023
• Last Update Posted: July 20, 2023
• Last Verified: July 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical