Evaluation of the efficacy of a food supplement on hair trophism and normal growth in subjects with androgenetic alopecia

ISRCTN	ISRCTN14004195
DOI	https://doi.org/10.1186/ISRCTN14004195
Clinical Study Protocol	EC_0003703/2024
Sponsor	BIONAP S.r.l.
Funder	BIONAP S.r.l.

Submission date: 27/01/2026
Registration date: 30/01/2026
Last edited: 27/01/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Roberta Villa
Scientific, Public

Viale Indipendenza 11, Pavia (PV)
Pavia
27100
Italy

Phone	+39 0382 25504
Email	roberta.villa@complifegroup.com

Dr Enza Cestone
Principal investigator

Via Monsignor Angelini 21, San Martino Siccomario (PV)
San Martino Siccomario
27028
Italy

Phone	+39 0382 25504
Email	info@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment, Safety and Efficacy
Scientific title	Clinical evaluation of the efficacy of a food supplement on hair trophism and normal growth in subjects with androgenetic alopecia: a randomized, double-blind, parallel-group, placebo-controlled study
Study acronym	ActrisaveSuppHair
Study objectives	The primary objective of this study is to evaluate the efficacy of the product in improving hair trophism and growth, in subjects with androgenetic alopecia. The secondary objective of this study is to evaluate the efficacy of the product in improving hair radiance, volume, thickness and structure.
Ethics approval(s)	Approved 25/11/2025, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), Lainate, 20045, Italy; +39 3783037302; secretariat@ieicomittee.com), ref: IC006 A
Health condition(s) or problem(s) studied	Healthy volunteers with androgenetic alopecia
Intervention	The active intervention is a blend of Oryza sativa (L.) and Opuntia cus indica (L.) extracts (Actrisave™), while the placebo intervention contains the same excipients without the active extract. A restricted randomization list will be generated by an independent technician using the appropriate algorithm ("Wei’s urn") of the PASS 11 software (PASS, LLC. Kaysville, UT, USA) and stored in a secure location. The Principal Investigator or designated personnel will dispense the products according to the randomization list generated. The study will be double-blind, meaning that subjects, Principal Investigator and collaborators are kept masked to products assignment. Both the active and placebo will be supplied in the same packaging with no obvious differences between them. Subjects take the assigned treatment for 6 months as follows: one capsules per day intake after breakfast with water.
Intervention type	Supplement
Primary outcome measure(s)	Hair density (anagen and telogen) and thickness measured using TrichoScan® supplier and software at baseline and after 3, 6, and 7 months
Key secondary outcome measure(s)	Hair morphology and structure measured using Scanning Electron Microscopy (SEM) for the assessment of hair morphology based on the condition of the cuticle, while hair structure is evaluated using a clinical scoring system. Variations from baseline (T0) are assessed through the analysis of digital photographs and rated on a 7-point Likert scale: Greatly decreased (−3), Moderately decreased (−2), Slightly decreased (−1), No change (0), Slightly increased (+1), Moderately increased (+2), and Greatly increased (+3) at baseline and after 3, 6, and 7 months Hair gloss measured using a spectrophotometer/colorimeter CM 700D (Konica Minolta) by the 8° gloss value at baseline and after 3, 6, and 7 months Hair volume measured using a clinical scoring system, in which variation from T0 at subsequent observation time points is assessed through the analysis of digital photographs and rated on a 7-point Likert scale as follows: Greatly decreased (-3), Moderately decreased (-2), Slightly decreased (-1), No change (0), Slightly increased (+1), Moderately increased (+2), Greatly increased (+3) at baseline and after 3, 6, and 7 months Hair radiance measured using a clinical scoring system, in which variation from T0 at subsequent observation time points is assessed through the analysis of digital photographs and rated on a 7-point Likert scale as follows: Greatly decreased (-3), Moderately decreased (-2), Slightly decreased (-1), No change (0), Slightly increased (+1), Moderately increased (+2), Greatly increased (+3) at baseline and after 3, 6, and 7 months Hair growth measured using a clinical scoring system, in which variation from T0 at subsequent observation time points is assessed through the analysis of digital photographs and rated on a 7-point Likert scale as follows: Greatly decreased (-3), Moderately decreased (-2), Slightly decreased (-1), No change (0), Slightly increased (+1), Moderately increased (+2), Greatly increased (+3) at baseline and after 3, 6, and 7 months Inflammatory status measured using blood analysis for hs-C-Reactive Protein (hs-CRP) at baseline and after 3, 6, and 7 months. Assess renal tolerability measured using blood analysis for creatinine at baseline and after 3, 6, and 7 months Hepatic tolerability measured using blood analysis for: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-Glutamyl Transferase (GGT) at baseline and after 3, 6, and 7 months Hematological monitoring measured using blood analysis for complete blood count (CBC): red blood cells, leukocyte count, hemoglobin, hematocrit and platelets at baseline and after 3, 6, and 7 months Product acceptability measured using a self-evaluation questionnaire (multiple choice and open-ended questions) at 3, 6, and 7 months
Completion date	23/10/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	64 Years
Sex	Female
Target sample size at registration	88
Key inclusion criteria	1. Healthy female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 64 years (extremes included) 4. Subjects with mild to moderate androgenetic alopecia * 5. Subjects with hair that is at least 5 cm long 6. Subjects with dull and mild to moderately damaged 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 centre 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 * From I to II on Ludwig scale ** Subjects are asked not to change their usual hair hygiene and styling products (such as shampoo, conditioner, hair gel, hairspray, etc.) throughout the study
Key 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.) 14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential). * Including oncological diseases, diabetes, autoimmune diseases, acute inflammatory diseases, ongoing infectious diseases, and alopecia areata. **** Including corticosteroid drugs, biological drugs, and cytostatic drugs.
Date of first enrolment	15/12/2025
Date of final enrolment	13/03/2026

Locations

Countries of recruitment

Italy

Study participating centres

Complife Italia S.r.l.

Via Monsignor Angelini 21, San Martino Siccomario (PV), Italy
San Martino Siccomario
27028
Italy

Complife Italia S.r.l.

Corso San Maurizio 25, Biella (PV), Italy
Biella
13900
Italy

Complife Italia S.r.l.

Via Signorelli 159, Garbagnate Milanese (MI), Italy
Garbagnate MIlanese
20024
Italy

Complife Italia S.r.l.

Piazzale Siena 11, Milano (MI), Italy
Milano
20146
Italy

Nutratech S.r.l.

Via Francesco Todaro 20/22, Rende (CS), Italy
Rende
87036
Italy

Complife Italia S.r.l.

Via Mortara 171, Ferrara (FE), Italy
Ferrara
44121
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

27/01/2026: Study’s existence confirmed by the International Ethics and Integrity Committee, Italy.