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

NCT06028295 | Completed

• 1 other identifier: IT0003622/23
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Telogen hair proportion

  Phototrichogram

  Baseline

• Telogen hair proportion

  Phototrichogram

  56 days

• Telogen hair proportion

  Phototrichogram

  84 days

Secondary Outcomes (10)

• Anagen hair proportion

  Baseline

• Anagen hair proportion

  56 days

• Anagen hair proportion

  84 days

• Hair growth

  84 days

• Hair elasticity

  Baseline

Study Arms (3)

Wheat Polar Lipid Complex Oil

EXPERIMENTAL

Dietary supplement - Wheat Polar Lipid Complex (Oil)

Dietary Supplement: Wheat Polar Lipid Complex Oil

Wheat Polar Lipid Complex Powder

EXPERIMENTAL

Dietary supplement - Wheat Polar Lipid Complex (Powder)

Dietary Supplement: Wheat Polar Lipid Complex Powder

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Wheat Polar Lipid Complex Oil DIETARY_SUPPLEMENT

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

Wheat Polar Lipid Complex Oil

Wheat Polar Lipid Complex Powder DIETARY_SUPPLEMENT

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

Wheat Polar Lipid Complex Powder

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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),
• No hair wash in the 48 hours before each visit,

Sponsors & Collaborators

• Seppic: lead

Study Sites (1)

Complife Italia srl

Milan, 20024, Italy

Location

Study Officials

• Ileana De Ponti

  Complife Italia S.r.l

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: September 4, 2023
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

IT (1)