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
1 other identifier
interventional
99
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2026
CompletedFirst Posted
Study publicly available on registry
September 8, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
September 8, 2026
September 1, 2026
4 months
August 27, 2026
September 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in anagen hair density
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
42 and 84 days
Secondary Outcomes (6)
Total number of hair in anagen phase
42 and 84 days
Change in telogene hair density
42 and 84 days
Number of hair protected against falling out (HPF)
42 ans 84 days
Change in total hair density
42 and 84 days
Change in hair brightness
42 and 84 days
- +1 more secondary outcomes
Other Outcomes (1)
Self-assessment questionnaire
42 and 84 days
Study Arms (3)
Active product 1
ACTIVE COMPARATORhard 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 COMPARATORhard 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 COMPARATORhard shell capsule containing maltodextrin
Interventions
one capsule per day during breakfast with water for 84 days
one capsule per day during breakfast with water for 84 days
one capsule per day during breakfast with water for 84 days
Eligibility Criteria
You may qualify if:
- 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 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Activ'insidelead
Study Sites (6)
Nutratech S.r.l. - Via Francesco Todaro 20/22
Rende, Cosenza, Italy
Complife Italia S.r.l. - Via Mortara 171
Ferrara, Ferrare, Italy
Complife Italia S.r.l. - Via Signorelli 159
Garbagnate Milanese, Milan, Italy
Complife Italia S.r.l. - Piazzale Siena 11
Milan, Milan, Italy
Complife Italia SRL - Corso San Maurizio 25
Biella, Pavia, Italy
Complife Italia S.r.l. - Via Monsignor Angelini 21
San Martino Siccomario, Pavia, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enza Cestone, Dr
Complife Italia Srl
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2026
First Posted
September 8, 2026
Study Start
September 30, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
September 8, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
confidential data