Clinical trial NCT06028295: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Seppic
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Telogen hair proportion
timeFrame: Baseline
measure: Telogen hair proportion
timeFrame: 56 days
measure: Telogen hair proportion
timeFrame: 84 days
Secondary outcomes:
measure: Anagen hair proportion
timeFrame: Baseline
measure: Anagen hair proportion
timeFrame: 56 days
measure: Anagen hair proportion
timeFrame: 84 days
measure: Hair growth
timeFrame: 84 days
measure: Hair elasticity
timeFrame: Baseline
measure: Hair elasticity
timeFrame: 84 days
measure: Hair loss
timeFrame: Baseline
measure: Hair loss
timeFrame: 56 days
measure: Hair loss
timeFrame: 84 days
measure: Self-assessment of product efficacy
timeFrame: 84 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Complife Italia srl
Study officials:
affiliation: Complife Italia S.r.l
name: Ileana De Ponti
role: STUDY_DIRECTOR
References: