Placebo-controlled assessment of the efficacy of a cosmetic product in subjects with hair shedding

ISRCTN	ISRCTN17506644
DOI	https://doi.org/10.1186/ISRCTN17506644
Clinical Study Protocol	EC_ PIT26/0000388 Ver. 00 of 18/09/2026
Study Code Order	H.E.HU.AL.NHL00.060.01.00_IT26_005796
Sponsor	Aroma-Zone
Funder	Aroma-Zone

Submission date: 09/11/2026
Registration date: 13/11/2026
Last edited: 11/11/2026

Recruitment status: No longer 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

Monsignor Angelini 21
San Martino Siccomario
27028
Italy

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

Dr Jessica Lacetera
Public, Scientific

Complife Iberia SLU
Calle del Capitán Arenas 3, Local 3
Barcelona
08028
Spain

Phone	+34 (0)936250201
Email	jessica.lacetera@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment
Scientific title	Placebo-controlled assessment of the efficacy of a cosmetic product in subjects with hair shedding: a randomized, double-blind, placebo-controlled clinical study
Study objectives	The primary objective of this study is to evaluate the efficacy of the product, in particular in reducing hair shedding. 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 29/09/2026, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), Lainate, 20045, Italy; +39 (0)3783037302; secretariat@ieicomittee.com), ref: Rif. IC0029 A
Health condition(s) or problem(s) studied	Transient acute telogen effluvium with different triggering causes (i.e., stress, environmental factors, seasonal changes, sudden hormonal changes)
Intervention	The active intervention is a multi-active topical scalp serum containing peptides and pea 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 generated randomization list: half of the subjects will be supplied with the active product, while the other half with 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 use the active treatment for 84 days ± 2 days as follows: separate your hair into several sections. Apply one to two drops to your scalp, making sure not to touch the skin with the dropper. Gently massage your scalp. Apply two times per day in the morning and at night. Clinical visits are planned at M0 (initial visit), M1 (follow-up visit, after 28 days ± 2 days of treatment), M2 (follow-up visit, after 56 ± 2 days of treatment) and M3 (final visit, after 84 ± 2 days of treatment).
Intervention type	Other
Primary outcome measure(s)	Hair anchorage force to scalp measured using a digital force gauge at M0, M1, M2 and M3 60-second hair count measured using Cleopatra 400 (Krest Combs, Leominster, Massachusetts) at M0, M1, M2 and M3 Total hair density, % anagen hair, % telogen hair, hair diameter, total number of hairs in anagen phase (THA) and the number of hairs protected against shedding measured using TrichoScan at M0, M1, M2 and M3 Hair elongation and force at break measured using a dynamometer at M0, M1, M2 and M3 Hair length and growth speed measured using hair length measured at M0, M1, M2 and M3 Hair volume and scalp appearance measured using scoring system at M0, M1, M2 and M3
Key secondary outcome measure(s)	Perceived efficacy and the pleasantness of the product measured using self-evaluation questionnaire (polytomous question with four possible answers) at M0, M1, M2 and M3 Digital pictures of the hair measured using pictures of three subjects (per group) showing the best effect at M0, M1, M2 and M3
Completion date	31/03/2027

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	66
Key inclusion criteria	1. Healthy female and male subjects 2. Subjects aged between 18 and 60 years old (extremes included) 3. Subjects must have transient acute telogen effluvium* with different triggering causes (i.e., stress, environmental factors, seasonal changes, sudden hormonal changes, including at least one subject postpartum) 4. Subjects registered with the national public health system in the country where the study is conducted 5. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 6. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 7. 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 8. Subjects who commit not to change their daily routine or lifestyle during the study** 9. 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 10. Subjects informed about the test procedures who have signed a consent form and privacy agreement * Hair shedding of less than 6 months’ duration, with rapid onset following a triggering event. In the final report for each volunteer will be specify the trigger cause or causes among those listed above. ** Subjects are asked to avoid dyeing, bleaching, perms, or hairstyles involving tension/pulling during 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 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	21/10/2026
Date of final enrolment	11/11/2026

Locations

Countries of recruitment

Georgia

Study participating centre

LTD Health

31/35, L. Asatiani & Zubalashvili Street
Batumi
6004
Georgia

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

09/11/2026: Study's existence confirmed by Complife.