Healthy VolunteersNCT05954039
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
A study testing Wheat Polar Lipid Complex in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Wheat Polar Lipid Complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 7 Sep 2022to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Wheat Polar Lipid Complex, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat Polar Lipid ComplexDietary supplement
The study foresees the intake of 2 capsules per day during 84 days
PlaceboDietary supplement
The study foresees the intake of 2 capsules per day during 84 days
| Study group | Role | What they receive |
|---|---|---|
| Wheat Polar Lipid Complex | Experimental | Dietary supplement - Wheat Polar Lipid Complex Receives: Dietary Supplement: Wheat Polar Lipid Complex |
| Placebo | Placebo comparator | Dietary supplement - Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telogen hair proportion
Phototrichogram
Measured: Baseline
Telogen hair proportion
Phototrichogram
Measured: 56 days
Telogen hair proportion
Phototrichogram
Measured: 84 days
Secondary outcomes (21)
Anagen hair proportion
Phototrichogram
Measured: Baseline
Anagen hair proportion
Phototrichogram
Measured: 56 days
Anagen hair proportion
Phototrichogram
Measured: 84 days
Hair growth
Hair length after shaving
Measured: 84 days
Hair elasticity
Hair elongation using dynamometer
Measured: Baseline
Hair elasticity
Hair elongation using dynamometer
Measured: 84 days
Scalp sebum content
Sebumeter
Measured: Baseline
Scalp sebum content
Sebumeter
Measured: 56 days
Scalp sebum content
Sebumeter
Measured: 84 days
Hair diameter
Optical microscopy
Measured: Baseline
Hair diameter
Optical microscopy
Measured: 84 days
Hair loss
Pull test
Measured: Baseline
Hair loss
Pull test
Measured: 56 days
Hair loss
Pull test
Measured: 84 days
Hair density
Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)
Measured: Baseline
Hair density
Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)
Measured: 56 days
Hair density
Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight density and 10 = very important density)
Measured: 84 days
Hair volume
Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)
Measured: Baseline
Hair volume
Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)
Measured: 56 days
Hair volume
Clinical scoring (Visual analog scale from 0 to 10, where: 0 = very slight volume and 10 = very important volume)
Measured: 84 days
Self-assessment of product efficacy
Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start7 Sep 2022
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seppic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ileana De Ponti, Study director, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954039
- Sponsor's protocol ID
- IT0003492/22
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05954039
- Acronym / sponsor ID
- IT0003492/22
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- SeppicIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat Polar Lipid Complex | Experimental | Dietary Supplement: Wheat Polar Lipid ComplexDietary supplement - Wheat Polar Lipid Complex |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement - Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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%,
Key exclusion criteria (24 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat Polar Lipid ComplexThe study foresees the intake of 2 capsules per day during 84 days | Dietary supplement | Wheat Polar Lipid Complex |
| PlaceboThe study foresees the intake of 2 capsules per day during 84 days | Dietary supplement | Placebo |
Primary outcome
Telogen hair proportion
Time frame: Baseline
Phototrichogram
Telogen hair proportion
Time frame: 56 days
Phototrichogram
Telogen hair proportion
Time frame: 84 days
Phototrichogram
21 secondary outcomes
Anagen hair proportion
Time frame: Baseline
Anagen hair proportion
Time frame: 56 days
Anagen hair proportion
Time frame: 84 days
Hair growth
Time frame: 84 days
Hair elasticity
Time frame: Baseline
Hair elasticity
Time frame: 84 days
Scalp sebum content
Time frame: Baseline
Scalp sebum content
Time frame: 56 days
Scalp sebum content
Time frame: 84 days
Hair diameter
Time frame: Baseline
Hair diameter
Time frame: 84 days
Hair loss
Time frame: Baseline
Hair loss
Time frame: 56 days
Hair loss
Time frame: 84 days
Hair density
Time frame: Baseline
Hair density
Time frame: 56 days
Hair density
Time frame: 84 days
Hair volume
Time frame: Baseline
Hair volume
Time frame: 56 days
Hair volume
Time frame: 84 days
Self-assessment of product efficacy
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ileana De Ponti study director
Complife Italia Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat Polar Lipid Complex in people with Healthy Volunteers, run by Seppic at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telogen hair proportion (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.