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

ClinicalTrials.gov ID

NCT07806474

Lead Sponsor

Activ'insideINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

99Estimated

Last Update Posted

Sep 8, 2026Actual

Start Date

Sep 30, 2026Estimated

Primary Completion Date

Feb 1, 2027Estimated

Completion Date

Feb 1, 2027Estimated

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

Brief 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.

• Androgenic Alopecia
• Healthy Adult Male

• 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)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

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:

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 washout period (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, autoimmune diseases, acute inflammatory diseases, ongoing infectious diseases, and alopecia areata.

      • Including corticosteroid drugs, biological drugs, and cytostatic drugs.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Activ'insideINDUSTRY

jessica.lacetera@complifegroup.com0382 25504 ext. +39

• Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen Effluvium

  NCT06545552

  CompletedInterventionalNot ApplicableUpdated Jun 5, 2025
• Evaluation of the Dietary Supplement Efficacy Against Hair Loss in Subjects Suffering From Hair Loss

  NCT07358403

  CompletedInterventionalNot ApplicableUpdated Jan 26, 2026
• Six-Month Single-Blind, Placebo-Controlled Study of a Dietary Supplement Supplement on Hair Growth in 45 Volunteers

  NCT06841458

  RecruitingInterventionalNot ApplicableUpdated Feb 24, 2025
• Evaluation of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects

  NCT04884347

  CompletedInterventionalNot ApplicableUpdated May 13, 2021
• A Clinical Study to Assess Safety, Efficacy and In-use Tolerability of Different Dosages of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III).

  NCT06551818

  CompletedInterventionalNot ApplicableUpdated Jul 31, 2026
• Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss

  NCT02150187

  CompletedInterventionalPhase 2Updated Jul 18, 2017