Evaluation of the effects of a food supplement in improving acute telogen effluvium in male subjects

ISRCTN ISRCTN97191554
DOI https://doi.org/10.1186/ISRCTN97191554
Clinical Study Protocol Number EC_ PIT26/0000380
Study Code_Order H.E.HU.TE.NHL00.180.10.01_IT26/005873
Sponsor BCF Life Sciences
Funder BCF Life Sciences
Submission date
14/08/2026
Registration date
09/09/2026
Last edited
28/08/2026
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

Not provided at time of registration

Contact information

Dr Enza Cestone
Principal investigator

Via Monsignor Angelini 21
San Martino Siccomario
27028
Italy

+39 (0)38225504
info@complifegroup.com
Dr Silvia Pimazzoni
Public, Scientific

Viale Indipendenza, 11
Pavia
27100
Italy

ORCiD logo 0000-0002-2574-4589
+39 (0)3783052587
silvia.pimazzoni@complifegroup.com

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlPlacebo
AssignmentParallel
PurposeEfficacy
Scientific titleClinical trial for the assessment of the efficacy of an ingredient in subjects with acute telogen effluvium: a randomized, double-blind, placebo-controlled clinical trial
Study objectives The primary objective of this study is to evaluate the efficacy of the product, in particular in reducing hair shedding in male subjects showing acute telogen effluvium. The secondary objective of this study is to evaluate the efficacy of the product in improving hair conditions and investigate the satisfaction and efficacy of the product perceived by the subjects.
Ethics approval(s)

Approved 29/07/2026, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), 20045, Italy; +39 (0)3783037302; secretariat@ieicomittee.com), ref: Rif. IC0024 A

Health condition(s) or problem(s) studiedAcute telogen effluvium
InterventionThe active supplement consists of a keratin hydrolysate formulation containing Kera-Diet as the active ingredient and rice starch as the excipient, while the placebo contains only maltodextrin.

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 a randomized and placebo-controlled list:
1. Twenty-two men (n = 22) will receive the active product at a dose of 500 mg/day
2. Twenty-two men (n = 22) will receive the placebo

The study will be double-blind, meaning that subjects, Principal Investigator and collaborators are kept masked to products assignment. The products will be supplied in the same packaging with no obvious differences between them.

Subjects take the assigned treatment for 3 months as follows: two capsules per day in the morning, with a glass of water.

The study will last 3 months. T1 refers to the 1-month time point, while T3 refers to the final time point (3 months).
Intervention typeSupplement
Primary outcome measure(s)
  1. Hair diameter (μm) measured using TrichoScan® supplier and software at baseline, T1 and T3 (a follow-up visit is scheduled 48 hours after the visit for the assessment of phototrichogram parameters)
  2. Anagen hair (%) measured using TrichoScan® supplier and software at baseline, T1 and T3 (a follow-up visit is scheduled 48 hours after the visit for the assessment of phototrichogram parameters)
  3. Telogen hair (%) measured using TrichoScan® supplier and software at baseline, T1 and T3 (a follow-up visit is scheduled 48 hours after the visit for the assessment of phototrichogram parameters)
  4. Total number of hairs in anagen phase (THA) measured using TrichoScan® supplier and software at baseline, T1 and T3 (a follow-up visit is scheduled 48 hours after the visit for the assessment of phototrichogram parameters)
  5. Total number of hairs protected against shedding (HPF) measured using TrichoScan® supplier and software at baseline, T1 and T3 (a follow-up visit is scheduled 48 hours after the visit for the assessment of phototrichogram parameters)
  6. Hair density (number/cm2) measured using TrichoScan® supplier and software at baseline, T1 and T3 (a follow-up visit is scheduled 48 hours after the visit for the assessment of phototrichogram parameters)
  7. Number of extracted hairs measured using the Pull test at baseline, T1 and T3
  8. Number of hair sheds during washing measured using the Wash test at baseline, T1 and T3
  9. Hair shedding visual scoring measured using the Sinclair Hair Shedding Scale at baseline, T1 and T3
  10. Hair elongation (hair elasticity) measured using Dynamometer (C610M Auto Tensile Tester, Labthink) at baseline, T1 and T3
  11. Assessment of the hair anchorage force to scalp measured using digital force gauge at baseline, T1 and T3
  12. Scalp appearance measured using dermatoscope at baseline, T1 and T3
  13. Scalp hydration measured using DermaLab Hydration Pin Probe at baseline, T1 and T3
  14. Hair growth rate (expressed as the ratio between the hair length and the time) measured using a millimeter-graduated ruler at baseline, T1 and T3
Key secondary outcome measure(s)
  1. Digital pictures measured using a digital camera at baseline, T1 and T3
  2. Images of hair measured using scanning electronic microscopy (SEM) at baseline, T1 and T3
  3. Efficacy perceived and the pleasantness of the product measured using a self-evaluation questionnaire at T1 and T3
Completion date26/02/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit65 Years
SexMale
Target sample size at registration44
Key inclusion criteria1. Healthy male subjects
2. Subjects with skin types I to IV all included with no specific distribution across phototype groups.
3. Subjects aged between 18 and 65 years (extremes included)
4. Subjects with acute telogen effluvium with a minimum hair length by 5 cm (men) at the recruitment
5. Subjects registered with the national public health system in the country where the study is conducted
6. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
7. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
8. 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
9. Subjects who commit not to change their daily routine or lifestyle during the study*
10. Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least 1 month without any changes expected or planned during the study
11. Subjects informed about the test procedures who have signed a consent form and privacy agreement

*Subjects are asked not to change their usual dietary style, and hair hygiene and styling products (such as shampoo, conditioner, hair gel, hairspray, etc) throughout the study
Key exclusion criteria1. Subjects with kinky hair
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 1 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)
Date of first enrolment17/08/2026
Date of final enrolment13/11/2026

Locations

Countries of recruitment

  • China
  • France
  • Georgia
  • Italy
  • Romania
  • South Africa
  • Spain
  • Ukraine

Study participating centres

Complife Italia SRL
Piazzale Siena 11
Milano
20146
Italy
Complife Italia SRL
Via Fratelli Signorelli 159
Garbagnate Milanese
20024
Italy
Complife Italia SRL
Via Monsignor Angelini 21
San Martino Siccomario
Italy
Complife Italia SRL
Corso San Maurizio, 25
Biella
13900
Italy
Complife Italia SRL
Via Mortara 171
Ferrara
44121
Italy
Nutratech SRL
via F. Todaro 20/22
Rende
Italy
Complife France SAS
LE QUADRILLE, 18 rue Jacqueline Auriol
Lyon
69008
France
Complife South Africa Pty Ltd
Unit H 3, The Willows Office Park, c/o Simon Vermooten and Farm Roads, The Willows
Pretoria
South Africa
Complife Iberia SLU
Calle del Capitán Arenas 3, Local 3
Barcelona
08028
Spain
Complife (Beijing) Testing Technology Co., Ltd
Beizhan North Street 17, Room 902, Xicheng District
Beijing
100089
China
Complife Romania SRL
Strada Orzari 92A
București
021554
Romania
LLC «CRH «Vidnovlennya»
4, Lubarska Street
Zhytomyr
10014
Ukraine
LTD HEALTH
31/35, L. Asatiani & Zubalashvili Street
Batumi
6004
Georgia

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

14/08/2026: Study's existence confirmed by the International Ethics and Integrity Committee.

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