Hair LossNCT04884347
Evaluation of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects
A study testing Alline proMEN in people with Hair Loss, run by Laboratoires Pharmaceutiques Trenker at 1 site in Italy.
Trial summary
According to the American Hair Loss Association, by the age of 35, two-thirds of American men will have some degree of appreciable hair loss, and by the age of 50, approximately 50 to 85% of men will have significant hair thinning. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Loss
- What is being tested?
- Alline proMEN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 31 Aug 2020to 4 Feb 2021
- 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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Criteria related to population
- Male subjects
- Caucasian ethnicity
- Subjects aged between 25 and 55 years old
- Subjects with all type of scalp and hair
- Phototype I to IV included, according to Fitzpatrick classification
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- Subjects registered with health social security or health social insurance
- Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
- Subjects certifying the truth of the personal information declared to the Investigator
- Subjects able to understand the language used in the investigation centre and the information given
- Subjects able to comply with the protocol and follow protocol's constraints and specific requirements
- Criteria related to subject's health
- Subjects considered "healthy subject" by the Investigator
- if the subject is under systemic pharmacological treatment, this should be stable for at least one month before the study start and do not change over the study period, excluded the treatments specified in noninclusion criteria"
- Criteria related to hair loss disorders
- Acute hair loss with a proportion of hair in telogen phase superior or equal to 20% as assessed by phototricogram
- Subjects agreeing to preserve a length of hair longer than 10 cm during the study
- Subjects agreeing to have a zone of 1.8 cm² shaved on the scalp
Who cannot join
- Criteria related to the population
- Subjects taking part or planning to participate to another clinical trial during the study in the same or another investigation centre
- Subjects deprived of freedom by administrative or legal decision or under guardianship Subjects not able to be contacted in case of emergency.
- Subjects admitted in a sanitary or social facility
- Subjects planning a hospitalisation during the study
- Subjects belonging to the staff of the investigation centre
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- subjects who have participated in another clinical trial with anti-hair loss product or treatment within the last 12 weeks before the inclusion visit
- Criteria related to subject's health
- Subjects 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
- Subjects being in course of a long-treatment or intending to have one, in particular with aspirin, products containing aspirin, corticoids, beta blockers (including eye drops), immuno-suppressive and/or desensitisation drugs or under any treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
- Subjects being vaccinated within the 3 weeks prior to the study or intending to be vaccinated during the course of the study
- Subjects having a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements Subjects having personal history of cosmetic, drug or domestic products irritative reactions Subjects having personal history of cosmetic products or adhesive plaster allergy Subjects having personal history of drug, domestic products and food allergy with no progressive or recent clinical features of allergy
- Criteria related to hair loss disorders
- Subjects who have any other diagnosed hair disorder or hair disease.
- Subjects having excessive and/or fluctuating hair shedding for more than 6 months Subjects with Inflammatory skin disease or progressive skin lesion on the scalp (psoriasis, seborrhoeic dermatitis, severe erythema, severe excoriation, severe sunburn, etc.). Subjects having a scalp lesion in relief which may be traumatized
- Subjects with history of hypersensitivity or intolerance to any of the following components applied by topical route: ethyl alcohol, components of the used hair dye, components of the studied product.
- Subjects having 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
- Subjects having 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
- Subjects having any other local treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole…) within the last 2 weeks before the inclusion visit
- Subjects having any following hair care within the last 2 weeks before the inclusion visit or foreseen during the study (except for dying): dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm
- Subjects having any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam…)
- Subjects under radiotherapy, chemotherapy at any time Subjects having 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 Assessment of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects
According to the American Hair Loss Association, by the age of 35, two-thirds of American men will have some degree of appreciable hair loss, and by the age of 50, approximately 50 to 85% of men will have significant hair thinning.
Hair is an essential aspect of human appearance and can have a significant impact on a person's self-esteem, mood and quality of life. Unfortunately, current treatment options can be costly, tedious or painful. They are also associated with numerous side effects.
Here, the investigators aimed at evaluating the effect of a new food supplement on hair condition in young men suffering from hair loss. A second goal was to determine tolerability.
- Conditions
- Hair Loss
- Being tested
- Alline proMEN, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alline proMENDietary supplement
1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months
PlaceboDietary supplement
1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months
| Study group | Role | What they receive |
|---|---|---|
| Alline proMEN | Experimental | The qualitative and quantitative formula is as follows: 500 mg Keratin, 225 mg Inactive dried yeast rich in vitamin (containing 200 mg Saccharomyces cerevisiae 100% inactivated, 11.218.4 mg Vitamin B3, 6.8-7.2 mg Vitamin B5, 1.6-1.8 mg Vitamin B6, 1.6-1.8 mg Vitamin B2, 1.6 -1.8 mg Vitamin B1, 0.2-0.4 mg Vitamin B9, 0.2 mg Vitamin B8, 5.6 μg Vitamin B12), 150 mg Venus hair fern extract, 117.6 mg Iron gluconate (containing 14.7 mg Iron), 84.2 mg Sodium ascorbate coated, 76.8 mg Zinc gluconate (11 mg Zinc) 24 mg Beta carotene 20%, 14.8 mg Vitamin E, 256.3 mg Acacia gum, 100 mg Microcrystalline cellulose, 11.3 mg Magnesium stearate, 78 mg White coating (containing: 23.4-39 mg Hydroxypropylmethylcellulose (E464), 15.6-23.4 mg Calcium sulfate anhydrous (E516), 15.6-23.4 mg Magnesium carbonate, light (E504), 7.8-15.6 mg Hydroxypropylcellulose (E463), 3.9-11.7 mg Stearic acid (E570)). Receives: Dietary Supplement: Alline proMEN |
| Placebo | Placebo comparator | 1095 mg Microcrystalline cellulose, 5 mg Magnesium stearate, 55 mg White coating (containing: 16.5-27.5 mg Hydroxypropylmethylcellulose (E464), 11.0-16.5 mg Calcium sulfate anhydrous (E516), 11.0-16.5 mg Magnesium carbonate, light (E504), 5.5-11.0 mg Hydroxypropylcellulose (E463), 2.8-8.2 mg Stearic acid (E570). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the number of hair in anagen and telogen phases at day 30 and 86.
The total number of hair (hair density) and the number of hair in the anagen phase will be determined by phototricogram. Briefly, all hairs in a 2 sq cm area are trimmed 1 mm from the skin surface. The hair is dyed and a baseline photograph is taken. After 48h, the same region is photographed again. By comparing with the baseline picture, one can observe as to which hair fibers have grown (follicles in anagen) and which have not (follicles in telogen) and the density of the hair (the number of hairs in the photograph). Anagen hair will be manually counted comparing side by side the photographs taken at each checkpoint and 48 hours after. Telogen hair will be calculated as the difference between the total hair number and the anagen hair number.
Measured: Day 0, Day 30, Day 86
Secondary outcomes (3)
Changes from baseline in hair radiance (au) at day 28 and day 84
Hair radiance will be measured by spectrophotometry.
Measured: Day 0, Day 28, Day 84
Changes from baseline in hair elongation (%) at day 28 and day 84
Hair elongation (hair elasticity) will be evaluated by means of dynamometer reading. The dynamometer reading will be done on a single hair fiber. In total 10 hair fibers/participant will be measured.
Measured: Day 0, Day 28, Day 84
Changes from baseline in hair breakage force (cN) at day 28 and day 84
The force at which the hair breaks (breakage force) will be evaluated by means of dynamometer reading. The dynamometer reading will be done on a single hair fiber. In total 10 hair fibers will be measured.
Measured: Day 0, Day 28, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start31 Aug 2020
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Pharmaceutiques Trenker
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Complife Italia Srl, University of Pavia
- Responsible party
- Sponsor
- Investigators
- Vincenzo Nobile, PhD, Study director, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884347
- Sponsor's protocol ID
- NHL00.100.13.00_ IT0002110/20
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo-controlled Assessment of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects
- ClinicalTrials.gov ID
- NCT04884347
- Acronym / sponsor ID
- NHL00.100.13.00_ IT0002110/20
- Conditions
- Hair Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Laboratoires Pharmaceutiques TrenkerIndustry (pharma, biotech, devices)
- Collaborators
- Complife Italia Srl, University of Pavia
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 13 May 2021 (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.
According to the American Hair Loss Association, by the age of 35, two-thirds of American men will have some degree of appreciable hair loss, and by the age of 50, approximately 50 to 85% of men will have significant hair thinning.
Hair is an essential aspect of human appearance and can have a significant impact on a person's self-esteem, mood and quality of life. Unfortunately, current treatment options can be costly, tedious or painful. They are also associated with numerous side effects.
Here, the investigators aimed at evaluating the effect of a new food supplement on hair condition in young men suffering from hair loss. A second goal was to determine tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alline proMEN | Experimental | Dietary Supplement: Alline proMENThe qualitative and quantitative formula is as follows: 500 mg Keratin, 225 mg Inactive dried yeast rich in vitamin (containing 200 mg Saccharomyces cerevisiae 100% inactivated, 11.218.4 mg Vitamin B3, 6.8-7.2 mg Vitamin B5, 1.6-1.8 mg Vitamin B6, 1.6-1.8 mg Vitamin B2, 1.6 -1.8 mg Vitamin B1, 0.2-0.4 mg Vitamin B9, 0.2 mg Vitamin B8, 5.6 μg Vitamin B12), 150 mg Venus hair fern extract, 117.6 mg Iron gluconate (containing 14.7 mg Iron), 84.2 mg Sodium ascorbate coated, 76.8 mg Zinc gluconate (11 mg Zinc) 24 mg Beta carotene 20%, 14.8 mg Vitamin E, 256.3 mg Acacia gum, 100 mg Microcrystalline cellulose, 11.3 mg Magnesium stearate, 78 mg White coating (containing: 23.4-39 mg Hydroxypropylmethylcellulose (E464), 15.6-23.4 mg Calcium sulfate anhydrous (E516), 15.6-23.4 mg Magnesium carbonate, light (E504), 7.8-15.6 mg Hydroxypropylcellulose (E463), 3.9-11.7 mg Stearic acid (E570)). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1095 mg Microcrystalline cellulose, 5 mg Magnesium stearate, 55 mg White coating (containing: 16.5-27.5 mg Hydroxypropylmethylcellulose (E464), 11.0-16.5 mg Calcium sulfate anhydrous (E516), 11.0-16.5 mg Magnesium carbonate, light (E504), 5.5-11.0 mg Hydroxypropylcellulose (E463), 2.8-8.2 mg Stearic acid (E570). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Criteria related to population
- Criteria related to subject's health
- Criteria related to hair loss disorders
Key exclusion criteria (22 listed)
- Criteria related to the population
- Criteria related to subject's health
- Criteria related to hair loss disorders
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 |
|---|---|---|
| Alline proMEN1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months | Dietary supplement | Alline proMEN |
| Placebo1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months | Dietary supplement | Placebo |
Primary outcome
Changes from baseline in the number of hair in anagen and telogen phases at day 30 and 86.
Time frame: Day 0, Day 30, Day 86
The total number of hair (hair density) and the number of hair in the anagen phase will be determined by phototricogram. Briefly, all hairs in a 2 sq cm area are trimmed 1 mm from the skin surface. The hair is dyed and a baseline photograph is taken. After 48h, the same region is photographed again. By comparing with the baseline picture, one can observe as to which hair fibers have grown (follicles in anagen) and which have not (follicles in telogen) and the density of the hair (the number of hairs in the photograph). Anagen hair will be manually counted comparing side by side the photographs taken at each checkpoint and 48 hours after. Telogen hair will be calculated as the difference between the total hair number and the anagen hair number.
3 secondary outcomes
Changes from baseline in hair radiance (au) at day 28 and day 84
Time frame: Day 0, Day 28, Day 84
Changes from baseline in hair elongation (%) at day 28 and day 84
Time frame: Day 0, Day 28, Day 84
Changes from baseline in hair breakage force (cN) at day 28 and day 84
Time frame: Day 0, Day 28, Day 84
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 13 May 2021.
- Individual participant dataSharing planned: No
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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.
Vincenzo Nobile, PhD 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 Alline proMEN in people with Hair Loss, run by Laboratoires Pharmaceutiques Trenker 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 18 inclusion and 22 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 13 May 2021. 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?
Changes from baseline in the number of hair in anagen and telogen phases at day 30 and 86. (time frame: Day 0, Day 30, Day 86). 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 13 May 2021.