ClinicalTrials.gg
RecruitingNCT07806474Updated Nov 9, 2026

Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia

An interventional study of 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 Androgenic Alopecia and Healthy Adult Male, sponsored by Activ'inside. Recruiting at 6 sites in Italy. Open to male participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Activ'inside · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Nov 9, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
Male
01

Study 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. 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.
02

Conditions studied

  • Androgenic Alopecia
  • Healthy Adult Male

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Keywords

  • food supplement
  • phototrichogram
  • hair loss
  • spectrophotometer
  • hair growth
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 99 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Activ'inside is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male subjects
  2. Subjects of Caucasian ethnicity
  3. Subjects aged between 35 and 65 years (extremes included)
  4. Subjects with mild to moderate androgenetic alopecia, corresponding to the grade II to III vertex on Hamilton-Norwood scale
  5. Subjects with hair that is at least 5-7 cm long
  6. Subjects with visible grey or white hair
  7. Subjects registered with national health service
  8. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
  9. Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel
  10. 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
  11. Subjects who commit not to change their daily routine or lifestyle during the study*
  12. 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
  13. 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

Exclusion criteria

Exclusion Criteria:

  1. Subjects who do not meet the inclusion criteria
  2. 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 **
  3. Subjects participating or planning to participate in other clinical trials
  4. Subjects who participated in a similar study without respecting an adequate (at least one month)
  5. Subjects that have food intolerances or food allergies to ingredients of the study product
  6. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator ***
  7. 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)
  8. Subjects admitted to a health or social facility
  9. Subjects planning a hospitalization during the study
  10. Subjects not able to be contacted in case of emergency
  11. Subjects deprived of freedom by administrative or legal decision or under guardianship
  12. Subjects who have or have had a history of alcohol or drug addiction
  13. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)

    • Including oncological diseases, diabetes, diseases, acute inflammatory diseases, ongoing infectious diseases, and alopecia areata.

      • Including drugs, biological drugs, and cytostatic drugs.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
99 participants (estimated)

Study arms

  • Active comparator
    Active product 1

    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

    Dietary Supplement: formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast

  • Active comparator
    Active product 2

    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

    Dietary Supplement: formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast

  • Placebo comparator
    Placebo

    hard shell capsule containing maltodextrin

    Dietary Supplement: Placebo (maltodextrin)

Interventions

  • Dietary supplementformulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast

    one capsule per day during breakfast with water for 84 days

  • Dietary supplementformulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast

    one capsule per day during breakfast with water for 84 days

  • Dietary supplementPlacebo (maltodextrin)

    one capsule per day during breakfast with water for 84 days

06

What researchers measure

Primary outcomes

  1. Change in anagen hair density

    Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)

    Time frame: 42 and 84 days

Secondary outcomes

  1. 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.

    Time frame: 42 and 84 days

  2. Change in telogene hair density

    Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)

    Time frame: 42 and 84 days

  3. 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).

    Time frame: 42 ans 84 days

  4. Change in total hair density

    Number of total hairs per cm² using phototricogram (TrichoScan)

    Time frame: 42 and 84 days

  5. 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).

    Time frame: 42 and 84 days

  6. 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).

    Time frame: 42 and 84 days

Other outcomes

  1. Self-assessment questionnaire

    Subjects are asked to reply to a self-assessment questionnaire to assess the efficacy perceived and the pleasantness of the product. Responses are provided spontaneously, without external influence.

    Time frame: 42 and 84 days

07

Study locations

6 of 6 sites recruiting
  • Nutratech S.r.l. - Via Francesco Todaro 20/22
    Rende, Cosenza, Italy
    Recruiting
  • Complife Italia S.r.l. - Via Mortara 171
    Ferrara, Ferrare, Italy
    Recruiting
  • Complife Italia S.r.l. - Via Signorelli 159
    Garbagnate Milanese, Milan, Italy
    Recruiting
  • Complife Italia S.r.l. - Piazzale Siena 11
    Milan, Milan, Italy
    Recruiting
  • Complife Italia SRL - Corso San Maurizio 25
    Biella, Pavia, Italy
    Recruiting
  • Complife Italia S.r.l. - Via Monsignor Angelini 21
    San Martino Siccomario, Pavia, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — confidential data

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.

Of 61 industry-sponsored interventional studies with no phase under Alopecia, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 5 months is below that.

Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 27.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: start Sep 2026 → Oct 2026, primary completion Feb 2027 → Mar 2027 and completion Feb 2027 → Mar 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 8, 2026
StartActual
Oct 5, 2026was Sep 2026
Primary completionEst.
Mar 5, 2027was Feb 2027
CompletionEst.
Mar 5, 2027was Feb 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
6 sites changed recruiting status (6 now recruiting)
Show 6 sites
  • Nutratech S.r.l. - Via Francesco Todaro 20/22 · Rende, Italyno status→Recruiting
  • Complife Italia S.r.l. - Via Mortara 171 · Ferrara, Italyno status→Recruiting
  • Complife Italia S.r.l. - Via Signorelli 159 · Garbagnate Milanese, Italyno status→Recruiting
  • Complife Italia S.r.l. - Piazzale Siena 11 · Milan, Italyno status→Recruiting
  • Complife Italia SRL - Corso San Maurizio 25 · Biella, Italyno status→Recruiting
  • Complife Italia S.r.l. - Via Monsignor Angelini 21 · San Martino Siccomario, Italyno status→Recruiting
Nov 9, 2026
Start date
Sep 30, 2026→Oct 5, 2026 (actual)
Nov 9, 2026
Primary completion
Feb 1, 2027→Mar 5, 2027
Nov 9, 2026
Study completion
Feb 1, 2027→Mar 5, 2027
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    6 sites changed recruiting status (6 now recruiting)
    Show 6 sites
    • Nutratech S.r.l. - Via Francesco Todaro 20/22 · Rende, Italyno status→Recruiting
    • Complife Italia S.r.l. - Via Mortara 171 · Ferrara, Italyno status→Recruiting
    • Complife Italia S.r.l. - Via Signorelli 159 · Garbagnate Milanese, Italyno status→Recruiting
    • Complife Italia S.r.l. - Piazzale Siena 11 · Milan, Italyno status→Recruiting
    • Complife Italia SRL - Corso San Maurizio 25 · Biella, Italyno status→Recruiting
    • Complife Italia S.r.l. - Via Monsignor Angelini 21 · San Martino Siccomario, Italyno status→Recruiting
    Start date Sep 30, 2026→Oct 5, 2026 (now actual)
    Primary completion Feb 1, 2027→Mar 5, 2027
    Study completion Feb 1, 2027→Mar 5, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07806474
Lead sponsor
Activ'inside
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Oct 5, 2026
Primary completion
Mar 5, 2027 (estimated)
Completion
Mar 5, 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Jessica Lacetera
Contact
jessica.lacetera@complifegroup.com
0382 25504 ext. +39
Enza Cestone, Dr
principal investigator · Complife Italia Srl

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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