Androgenic AlopeciaNCT07806474
Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia
A study testing formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast and formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast in people with Androgenic Alopecia and Healthy Adult Male, run by Activ'inside at 6 sites in Italy.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of two different formulations of a food supplement on hair health in healthy Caucasian male subjects aged 35 to 65 years with mild to moderate androgenetic alopecia. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men only
- Conditions the study is for
- Androgenic Alopecia, Healthy Adult Male
- What is being tested?
- formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast and formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 6 sitesItaly
- Study dates
- 30 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male subjects
- Subjects of Caucasian ethnicity
- Subjects aged between 35 and 65 years (extremes included)
- Subjects with mild to moderate androgenetic alopecia, corresponding to the grade II to III vertex on Hamilton-Norwood scale
- Subjects with hair that is at least 5-7 cm long
- Subjects with visible grey or white hair
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- Subjects registered with national health service
- Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
- Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel
- Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
- Subjects who commit not to change their daily routine or lifestyle during the study*
- Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
- Subjects informed about the test procedures who have signed a consent form and privacy agreement
- Subjects are asked not to change their usual hair hygiene and styling products (such as shampoo, conditioner, hair gel, hairspray, etc.) throughout the study
Who cannot join
- Subjects who do not meet the inclusion criteria
- Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study **
- Subjects participating or planning to participate in other clinical trials
- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- Subjects that have food intolerances or food allergies to ingredients of the study product
- Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator ***
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- Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
- Subjects admitted to a health or social facility
- Subjects planning a hospitalization during the study
- Subjects not able to be contacted in case of emergency
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects who have or have had a history of alcohol or drug addiction
- Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
- Including oncological diseases, diabetes, autoimmune diseases, acute inflammatory diseases, ongoing infectious diseases, and alopecia areata.
- Including corticosteroid drugs, biological drugs, and cytostatic drugs.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Italy6 sites
Complife Italia SRL - Corso San Maurizio 25
Biella, Pavia
Complife Italia S.r.l. - Via Mortara 171
Ferrara, Ferrare
Complife Italia S.r.l. - Via Signorelli 159
Garbagnate Milanese, Milan
Complife Italia S.r.l. - Piazzale Siena 11
Milan, Milan
Nutratech S.r.l. - Via Francesco Todaro 20/22
Rende, Cosenza
Complife Italia S.r.l. - Via Monsignor Angelini 21
San Martino Siccomario, Pavia
Jessica Lacetera, 0382 25504 ext. +39, jessica.lacetera@complifegroup.com
About this study
Official title: Clinical Efficacy and Safety of Two Food Supplements on Hair Health in Caucasian Male Subjects With Androgenic Alopecia : a Multicentric, Randomised, Double-blind, Placebo-controlled Clinical Study
The goal of this clinical trial is to evaluate the efficacy and safety of two different formulations of a food supplement on hair health in healthy Caucasian male subjects aged 35 to 65 years with mild to moderate androgenetic alopecia. The main questions it aims to answer are:
- Whether the two formulations improve hair growth and reduce hair loss after 42 and 84 days, as assessed by phototricogram parameters.
- Whether the two formulations improve hair brightness, and colour lightness after 42 and 84 days, as assessed by spectrophotometer/colorimeter.
Read more
Researchers will compare two active supplement groups and a placebo group to determine whether the active products improve objective hair parameters and perceived hair quality.
Participants will:
- be randomized to one of three groups : Active 1, Active 2 or Placebo;
- take one capsule daily at breakfast for 84 days;
- attend clinical visits at baseline, Day 42, and Day 84;
- undergo hair assessments including pull test, phototrichogram, and spectrophotometer/colorimeter measurements;
- complete a self-assessment questionnaire at follow-up visits;
- be monitored for safety and tolerability throughout the study.
- Conditions
- Androgenic Alopecia, Healthy Adult Male
- Being tested
- formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast, formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast, Placebo (maltodextrin)
- Keywords
- food supplement, phototrichogram, hair loss, spectrophotometer, hair growth
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeastDietary supplement
one capsule per day during breakfast with water for 84 days
formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeastDietary supplement
one capsule per day during breakfast with water for 84 days
Placebo (maltodextrin)Dietary supplement
one capsule per day during breakfast with water for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Active product 1 | Active comparator | hard shell capsule containing green tea leaf extract (Camellia sinensis (L.) Kuntze, Theaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin Receives: Dietary Supplement: formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast |
| Active product 2 | Active comparator | hard shell capsule containing grape seed extract (Vitis vinifera L., Vitaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin Receives: Dietary Supplement: formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast |
| Placebo | Placebo comparator | hard shell capsule containing maltodextrin Receives: Dietary Supplement: Placebo (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anagen hair density
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Measured: 42 and 84 days
Secondary outcomes (6)
Total number of hair in anagen phase
= (Anagen hair after supplement use x scalp surface) - (Anagen hair before supplement use x scalp surface) where the scalp surface is 580 cm2.
Measured: 42 and 84 days
Change in telogene hair density
Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Measured: 42 and 84 days
Number of hair protected against falling out (HPF)
(TEAF x SH) - (TEBE x SH)
where: TEAF is the number of telogen hair after supplement use ; TEBE is the number of telogen hair before product use; SH is the head surface (580cm2).
Measured: 42 ans 84 days
Change in total hair density
Number of total hairs per cm² using phototricogram (TrichoScan)
Measured: 42 and 84 days
Change in hair brightness
Hair brightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta). The measured parameter is the 8° gloss value (average value of the 5 measures).
Measured: 42 and 84 days
Change in hair colour lightness
Hair color lightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta). The measured parameter is the L* parameter (average value of the 5 measures) indicating the hair color lightness (i.e. lighter or darker hair).
Measured: 42 and 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Activ'inside
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enza Cestone, Dr, Principal investigator, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806474
- Sponsor's protocol ID
- EC_0000367/2026
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidential data
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Two Food Supplements on Hair Health in Caucasian Male Subjects With Androgenic Alopecia : a Multicentric, Randomised, Double-blind, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07806474
- Acronym / sponsor ID
- EC_0000367/2026
- Conditions
- Androgenic Alopecia, Healthy Adult Male
- Keywords
- food supplement, phototrichogram, hair loss, spectrophotometer, hair growth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Activ'insideIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Sep 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 clinical trial is to evaluate the efficacy and safety of two different formulations of a food supplement on hair health in healthy Caucasian male subjects aged 35 to 65 years with mild to moderate androgenetic alopecia. The main questions it aims to answer are:
- Whether the two formulations improve hair growth and reduce hair loss after 42 and 84 days, as assessed by phototricogram parameters.
- Whether the two formulations improve hair brightness, and colour lightness after 42 and 84 days, as assessed by spectrophotometer/colorimeter.
Researchers will compare two active supplement groups and a placebo group to determine whether the active products improve objective hair parameters and perceived hair quality.
Participants will:
- be randomized to one of three groups : Active 1, Active 2 or Placebo;
- take one capsule daily at breakfast for 84 days;
- attend clinical visits at baseline, Day 42, and Day 84;
- undergo hair assessments including pull test, phototrichogram, and spectrophotometer/colorimeter measurements;
- complete a self-assessment questionnaire at follow-up visits;
- be monitored for safety and tolerability throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active product 1 | Active comparator | Dietary Supplement: formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeasthard shell capsule containing green tea leaf extract (Camellia sinensis (L.) Kuntze, Theaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin |
| Active product 2 | Active comparator | Dietary Supplement: formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeasthard shell capsule containing grape seed extract (Vitis vinifera L., Vitaceae), bamboo shoot extract (Bambusa vulgaris Schrad., Poaceae), and selenium-enriched yeast (Saccharomyces cerevisiae) and maltodextrin |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (maltodextrin)hard shell capsule containing maltodextrin |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy male subjects
- Subjects of Caucasian ethnicity
- Subjects aged between 35 and 65 years (extremes included)
- Subjects with mild to moderate androgenetic alopecia, corresponding to the grade II to III vertex on Hamilton-Norwood scale
- Subjects with hair that is at least 5-7 cm long
Key exclusion criteria (15 listed)
- Subjects who do not meet the inclusion criteria
- Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study **
- Subjects participating or planning to participate in other clinical trials
- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- Subjects that have food intolerances or food allergies to ingredients of the study product
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 |
|---|---|---|
| formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeastone capsule per day during breakfast with water for 84 days | Dietary supplement | Active product 1 |
| formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeastone capsule per day during breakfast with water for 84 days | Dietary supplement | Active product 2 |
| Placebo (maltodextrin)one capsule per day during breakfast with water for 84 days | Dietary supplement | Placebo |
Primary outcome
Change in anagen hair density
Time frame: 42 and 84 days
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
6 secondary outcomes
Total number of hair in anagen phase
Time frame: 42 and 84 days
Change in telogene hair density
Time frame: 42 and 84 days
Number of hair protected against falling out (HPF)
Time frame: 42 ans 84 days
Change in total hair density
Time frame: 42 and 84 days
Change in hair brightness
Time frame: 42 and 84 days
Change in hair colour lightness
Time frame: 42 and 84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. confidential data
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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.
Enza Cestone, Dr principal investigator
Complife Italia Srl
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast and formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast in people with Androgenic Alopecia and Healthy Adult Male, run by Activ'inside at 6 sites 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 14 inclusion and 15 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Lacetera (0382 25504 ext. +39, jessica.lacetera@complifegroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anagen hair density (time frame: 42 and 84 days). 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 8 Sep 2026.