Healthy Volunteers
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWheat Polar Lipid Complex Oil
The study foresees the intake of 2 capsules per day during 84 days
DIETARY_SUPPLEMENTWheat Polar Lipid Complex Powder
The study foresees the intake of 2 capsules per day during 84 days
DIETARY_SUPPLEMENTPlacebo
The study foresees the intake of 2 capsules per day during 84 days
Sponsors
Seppic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Telogen hair proportion | Baseline | Phototrichogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anagen hair proportion | Baseline | Phototrichogram |
| Hair growth | 84 days | Hair length after shaving |
| Hair elasticity | Baseline | Hair elongation using dynamometer |
| Hair loss | Baseline | Pull test |
| Self-assessment of product efficacy | 84 days | Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree) |
Countries
Italy
Outcome results
None listed