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NCT Number: NCT07806474

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

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nutratech S.r.l. - Via Francesco Todaro 20/22, Rende, Cosenza, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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 ***
  • 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.

Treatment and study plan

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

Dietary Supplement

one capsule per day during breakfast with water for 84 days

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

Dietary 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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Total number of hair in anagen phase

    Time frame: 42 and 84 days

    = (Anagen hair after supplement use x scalp surface) - (Anagen hair before supplement use x scalp surface) where the scalp surface is 580 cm2.

  2. Change in telogene hair density

    Time frame: 42 and 84 days

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

  3. Number of hair protected against falling out (HPF)

    Time frame: 42 ans 84 days

    (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).

  4. Change in total hair density

    Time frame: 42 and 84 days

    Number of total hairs per cm² using phototricogram (TrichoScan)

  5. Change in hair brightness

    Time frame: 42 and 84 days

    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).

  6. Change in hair colour lightness

    Time frame: 42 and 84 days

    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).

Other outcomes

  1. Self-assessment questionnaire

    Time frame: 42 and 84 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Lacetera

CONTACT

[email protected]

0382 25504 ext. +39

Sponsors and collaborators

Lead sponsor

Activ'inside

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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