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

ISRCTN	ISRCTN65639513
DOI	https://doi.org/10.1186/ISRCTN65639513
Clinical Study Protocol Number	EC_ PIT26/0000380
H.E.HU.TE.NHL00.180.10.01_IT26/005873	Study Code_Order
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 (PV)
San Martino Siccomario
27028
Italy

Phone	+39 (0)38225504
Email	info@complifegroup.com

Dr Silvia Pimazzoni
Public, Scientific

Viale Indipendenza, 11
Pavia
27100
Italy

ORCID ID	0000-0002-2574-4589
Phone	+39 (0)3783052587
Email	silvia.pimazzoni@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Efficacy
Scientific title	Clinical 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 female 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, 20045, Italy; +39 (0)3783037302; secretariat@ieicomittee.com), ref: Rif. IC0024 A
Health condition(s) or problem(s) studied	Acute telogen effluvium
Intervention	The 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. Forty-four women (n = 44) will receive the active product at a dose of 300 mg/day 2. Forty-four women (n = 44) will receive the active product at a dose of 500 mg/day 2. Forty-four women (n = 44) 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. Participants 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 type	Supplement
Primary outcome measure(s)	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) 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) 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) 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) 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) 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) Number of extracted hairs measured using the Pull test at baseline, T1 and T3 Number of hair sheds during washing measured using the Wash test at baseline, T1 and T3 Hair shedding visual scoring measured using the Sinclair Hair Shedding Scale at baseline, T1 and T3 Hair elongation (hair elasticity) measured using dynamometer (C610M Auto Tensile Tester, Labthink) at baseline, T1 and T3 Assessment of the hair anchorage force to scalp measured using digital force gauge at baseline, T1 and T3 Scalp appearance measured using dermatoscope at baseline, T1 and T3 Scalp hydration measured using DermaLab Hydration Pin Probe at baseline, T1 and T3 Hair growth rate (expressed as the ratio between the hair length and the time) measured using millimeter-graduated ruler at baseline, T1 and T3
Key secondary outcome measure(s)	Digital pictures measured using digital camera at baseline, T1 and T3 Images of hair measured using scanning electronic microscopy (SEM) at baseline, T1 and T3 Efficacy perceived and the pleasantness of the product measured using self-evaluation questionnaire at T1 and T3
Completion date	26/02/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Female
Target sample size at registration	132
Key inclusion criteria	1. Healthy female 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, long hair (women) 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 criteria	1. 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 1 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) 14. Subjects breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
Date of first enrolment	17/08/2026
Date of final enrolment	13/11/2026

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
27028
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
87036
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 share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file			14/08/2026	No	No

Additional files

50097_PROTOCOL.pdf: Protocol file

Editorial Notes

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