Androgenetic Alopecia (AGA)NCT07358403
Evaluation of the Dietary Supplement Efficacy Against Hair Loss in Subjects Suffering From Hair Loss
A study testing Dietary supplement capsule use for hair loss and Dietary supplement drinklable use for hair loss in people with Androgenetic Alopecia (AGA) and Chronic Telogen Effluvium, run by Lacer S.A. at 1 site in Italy.
Trial summary
The goal of this study was to learn if dietary supplement in capsules and drinkable works to help hair loss in volunteers with chronic telogen effluvium and androgenetic alopecia and learn about its safety. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia (AGA), Chronic Telogen Effluvium
- What is being tested?
- Dietary supplement capsule use for hair loss and Dietary supplement drinklable use for hair loss
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2024to 26 Sep 2025
- 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 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female and male subjects, including at least 70% female subjects aged over 30 years old ✓ Caucasian ethnicity
- Aged between 18 and 62 years old (extreme included)
- 50% of subjects with chronic telogen effluvium (stage from 2 to 4, according to Sinclair scale for female pattern hair loss in women and modified Sinclair scale for female pattern hair loss in men)
- 50% of subjects with androgenetic alopecia (AGA): female subjects Ludwig scale (score I-II) and male subjects Hamilton- Norwood scale (vertex II-III)
- Subjects aware of the study procedures and having signed an informed consent form
- Subjects registered with National Health Service (NHS)
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- Subjects certifying the truthfulness of the personal data disclosed to the investigator
- Subjects able to understand the language used in the investigation and to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- Commitment not to change the daily routine or the lifestyle
- Subject informed about the study procedures and having signed the privacy policy
Who cannot join
- Subjects who do not fit the inclusion criteria.
- Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
- Subjects admitted to a health or social facility
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- Subjects planning a hospitalization during the study
- Subjects who participated in a similar study without respecting an adequate washout period (3 months)
- Alimentary/Eating disorders (i.e., bulimia, psychogenic eating disorders, etc.)
- Food allergy or food intolerances
- Impaired immune system due to i-mmunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
- Subjects who have any type of gastrointestinal disease or disorders (Chrons disease, colitis, irritable bowel syndrome, intestinal malabsorption)
- Pharmacological treatment (topic or systemic) known to interfere with the tested product or having effect on metabolism (e.g.: anticoagulants, antidepressants, drugs used to lower cholesterol levels, antiviral drugs and beta-blockers)
- Subjects having frequent stomach burn
- Cosmetic treatment known to interfere with the tested product (e.g.: anti-hair loss shampoo, antihair loss food supplements, anti-hair loss serum) during the study and in the last 3 months before study start
- Subjects who intends to carry out any straightening, permanent or other treatments on hair (hair botox,etc)
- Subjects with drandruff, seborrheic dermatitis or any other hair condition
- Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Instrumental Evaluation of the Efficacy of a Dietary Supplement Claiming Anti Hair Loss Properties
The goal of this study was to learn if dietary supplement in capsules and drinkable works to help hair loss in volunteers with chronic telogen effluvium and androgenetic alopecia and learn about its safety. The main questions it aims to answer are:
- Does dietary supplement in capsules and drinkable reduces hair loss in women and men suffering from chronic telogen effluvium or androgenetic alopecia?
- Were the products well accepted by the subjects from their´s perspective? Researchers will compare dietary supplement in capsules and drinkable to a placebo (a look-alike substance that contains no active ingredients) to see if dietary supplements works to reduce hair loss.
Read more
Participants will:
- Take assigned diatry supplement in capsule or drinkable or a placebo every day for 6 months
- Visit the study facility once every 3 months for evaulations
- Keep a diary of the product use
- Being tested
- Dietary supplement capsule use for hair loss, Dietary supplement capsule placebo use for hair loss, Dietary supplement drinklable use for hair loss, Dietary supplement drinklable placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement capsule use for hair lossDietary supplement
Dietary supplement capsule use for hair loss, once a day during 6 months.
Dietary supplement capsule placebo use for hair lossDietary supplement
Dietary supplement capsule placebo use for hair loss, once a day during 6 months.
Dietary supplement drinklable use for hair lossDietary supplement
Dietary supplement drinklable use for hair loss, once a day during 6 months.
Dietary supplement drinklable placeboDietary supplement
Dietary supplement drinklable placebo use for hair loss, once a day during 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement capsule | Experimental | Dietary supplement capsule was taken by the subjects daily during 6 months Receives: Dietary Supplement: Dietary supplement capsule use for hair loss |
| Dietary supplement capsule placebo | Placebo comparator | Dietary supplement capsule placebo was taken by the subjects daily during 6 months Receives: Dietary Supplement: Dietary supplement capsule placebo use for hair loss |
| Dietary supplement drinkable | Experimental | Dietary supplement drinkable was taken by the subjects daily during 6 months Receives: Dietary Supplement: Dietary supplement drinklable use for hair loss |
| Dietary supplement drinkable placebo | Placebo comparator | Dietary supplement drinkable placebo was taken by the subjects daily during 6 months Receives: Dietary Supplement: Dietary supplement drinklable placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the hair density at 3 and 6 months
Pictures of chosen area of the scalp are taken and the number of hairs per cm2 is counted.
Measured: From the baseline, at 3 months and at the end of the study (6 months).
Secondary outcomes (1)
Assessment of product acceptability and perceived efficacy at 3 and 6 months
Subjects responded questionnaire regarding product cosmetic qualities and efficacy where percentage of agreement with the statement was evaluated.
Measured: On 3 months and 6 months of product use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start4 Nov 2024
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lacer S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358403
- Sponsor's protocol ID
- IT0006736/24
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be shared in the paper.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Instrumental Evaluation of the Efficacy of a Dietary Supplement Claiming Anti Hair Loss Properties
- ClinicalTrials.gov ID
- NCT07358403
- Acronym / sponsor ID
- IT0006736/24
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Lacer S.A.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 22 Jan 2026 (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 goal of this study was to learn if dietary supplement in capsules and drinkable works to help hair loss in volunteers with chronic telogen effluvium and androgenetic alopecia and learn about its safety. The main questions it aims to answer are:
- Does dietary supplement in capsules and drinkable reduces hair loss in women and men suffering from chronic telogen effluvium or androgenetic alopecia?
- Were the products well accepted by the subjects from their´s perspective? Researchers will compare dietary supplement in capsules and drinkable to a placebo (a look-alike substance that contains no active ingredients) to see if dietary supplements works to reduce hair loss.
Participants will:
- Take assigned diatry supplement in capsule or drinkable or a placebo every day for 6 months
- Visit the study facility once every 3 months for evaulations
- Keep a diary of the product use
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement capsule | Experimental | Dietary Supplement: Dietary supplement capsule use for hair lossDietary supplement capsule was taken by the subjects daily during 6 months |
| Dietary supplement capsule placebo | Placebo comparator | Dietary Supplement: Dietary supplement capsule placebo use for hair lossDietary supplement capsule placebo was taken by the subjects daily during 6 months |
| Dietary supplement drinkable | Experimental | Dietary Supplement: Dietary supplement drinklable use for hair lossDietary supplement drinkable was taken by the subjects daily during 6 months |
| Dietary supplement drinkable placebo | Placebo comparator | Dietary Supplement: Dietary supplement drinklable placeboDietary supplement drinkable placebo was taken by the subjects daily during 6 months |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy female and male subjects, including at least 70% female subjects aged over 30 years old ✓ Caucasian ethnicity
- Aged between 18 and 62 years old (extreme included)
- 50% of subjects with chronic telogen effluvium (stage from 2 to 4, according to Sinclair scale for female pattern hair loss in women and modified Sinclair scale for female pattern hair loss in men)
- 50% of subjects with androgenetic alopecia (AGA): female subjects Ludwig scale (score I-II) and male subjects Hamilton- Norwood scale (vertex II-III)
- Subjects aware of the study procedures and having signed an informed consent form
Key exclusion criteria (20 listed)
- Subjects who do not fit the inclusion criteria.
- Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
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 |
|---|---|---|
| Dietary supplement capsule use for hair lossDietary supplement capsule use for hair loss, once a day during 6 months. | Dietary supplement | Dietary supplement capsule |
| Dietary supplement capsule placebo use for hair lossDietary supplement capsule placebo use for hair loss, once a day during 6 months. | Dietary supplement | Dietary supplement capsule placebo |
| Dietary supplement drinklable use for hair lossDietary supplement drinklable use for hair loss, once a day during 6 months. | Dietary supplement | Dietary supplement drinkable |
| Dietary supplement drinklable placeboDietary supplement drinklable placebo use for hair loss, once a day during 6 months. | Dietary supplement | Dietary supplement drinkable placebo |
Primary outcome
Change from Baseline in the hair density at 3 and 6 months
Time frame: From the baseline, at 3 months and at the end of the study (6 months).
Pictures of chosen area of the scalp are taken and the number of hairs per cm2 is counted.
1 secondary outcome
Assessment of product acceptability and perceived efficacy at 3 and 6 months
Time frame: On 3 months and 6 months of product use.
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 26 Jan 2026.
- Individual participant dataSharing planned: No. The results will be shared in the paper.
Related trials for Androgenetic Alopecia (AGA)
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Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement capsule use for hair loss and Dietary supplement drinklable use for hair loss in people with Androgenetic Alopecia (AGA) and Chronic Telogen Effluvium, run by Lacer S.A. 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 11 inclusion and 20 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 26 Jan 2026. 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?
Change from Baseline in the hair density at 3 and 6 months (time frame: From the baseline, at 3 months and at the end of the study (6 months).). 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 26 Jan 2026.