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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Androgenic Alopecia; Healthy Adult Male
• Intervention / Treatment: Dietary supplement: formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast; Dietary supplement: formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast; Dietary supplement: Placebo (maltodextrin)

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Lacetera; Phone Number: +39 0382 25504; Email: jessica.lacetera@complifegroup.com

Study Locations

• Italy
  • Cosenza
    • Rende, Cosenza, Italy
      • Nutratech S.r.l. - Via Francesco Todaro 20/22
  • Ferrare
    • Ferrara, Ferrare, Italy
      • Complife Italia S.r.l. - Via Mortara 171
  • Milan
    • Garbagnate Milanese, Milan, Italy
      • Complife Italia S.r.l. - Via Signorelli 159
    • Milan, Milan, Italy
      • Complife Italia S.r.l. - Piazzale Siena 11
  • Pavia
    • Biella, Pavia, Italy
      • Complife Italia SRL - Corso San Maurizio 25
    • San Martino Siccomario, Pavia, Italy
      • Complife Italia S.r.l. - Via Monsignor Angelini 21
      • Contact: Jessica Lacetera; Phone Number: +39 0382 25504; Email: jessica.lacetera@complifegroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; one capsule per day during breakfast with water for 84 days
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; one capsule per day during breakfast with water for 84 days
Placebo Comparator: Placebo; hard shell capsule containing maltodextrin	Dietary supplement: Placebo (maltodextrin); one capsule per day during breakfast with water for 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anagen hair density	Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)	42 and 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	42 and 84 days
Change in telogene hair density	Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)	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).	42 ans 84 days
Change in total hair density	Number of total hairs per cm² using phototricogram (TrichoScan)	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).	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).	42 and 84 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	42 and 84 days

Collaborators and Investigators

• Sponsor: Activ'inside
• Investigators: Principal Investigator: Enza Cestone, Dr, Complife Italia Srl

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: food supplement; hair loss; hair growth; phototrichogram; spectrophotometer
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; maltodextrin
• Other Study ID Numbers: EC_0000367/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: confidential data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No