Healthy Volunteers Clinical Trial
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
Verified date | July 2023 |
Source | Seppic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | December 23, 2022 |
Est. primary completion date | December 23, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Complife Italia srl | Milano |
Lead Sponsor | Collaborator |
---|---|
Seppic |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Telogen hair proportion | Phototrichogram | Baseline | |
Primary | Telogen hair proportion | Phototrichogram | 56 days | |
Primary | Telogen hair proportion | Phototrichogram | 84 days | |
Secondary | Anagen hair proportion | Phototrichogram | Baseline | |
Secondary | Anagen hair proportion | Phototrichogram | 56 days | |
Secondary | Anagen hair proportion | Phototrichogram | 84 days | |
Secondary | Hair growth | Hair length after shaving | 84 days | |
Secondary | Hair elasticity | Hair elongation using dynamometer | Baseline | |
Secondary | Hair elasticity | Hair elongation using dynamometer | 84 days | |
Secondary | Scalp sebum content | Sebumeter | Baseline | |
Secondary | Scalp sebum content | Sebumeter | 56 days | |
Secondary | Scalp sebum content | Sebumeter | 84 days | |
Secondary | Hair diameter | Optical microscopy | Baseline | |
Secondary | Hair diameter | Optical microscopy | 84 days | |
Secondary | Hair loss | Pull test | Baseline | |
Secondary | Hair loss | Pull test | 56 days | |
Secondary | Hair loss | Pull test | 84 days | |
Secondary | Hair density | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density) | Baseline | |
Secondary | Hair density | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density) | 56 days | |
Secondary | Hair density | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density) | 84 days | |
Secondary | Hair volume | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume) | Baseline | |
Secondary | Hair volume | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume) | 56 days | |
Secondary | Hair volume | Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume) | 84 days | |
Secondary | Self-assessment of product efficacy | Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree) | 84 days |
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