Clinical trial for the assessment of the efficacy of cosmetic product in improving hair conditions

ISRCTN	ISRCTN38154037
DOI	https://doi.org/10.1186/ISRCTN38154037
Clinical study protocol number	EC_ 0000200/26
Study Code_Order	H.E.HU.MP.NHL00.040.02.00_IT0001994/26
Sponsor	SKIN FIRST COSMETICS S.R.L
Funder	SKIN FIRST COSMETICS S.R.L

Submission date: 07/05/2026
Registration date: 05/06/2026
Last edited: 07/05/2026

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

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

Phone	+39 38225504
Email	info@complifegroup.com

Dr Anna Pelizzola
Scientific, Public

Viale Indipendenza, 11, Pavia (PV)
Pavia
27100
Italy

Phone	+39 38225504
Email	anna.pelizzola@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment, Efficacy
Scientific title	Clinical trial for the assessment of the efficacy of cosmetic product in improving hair conditions: a randomized, double-blind, placebo-controlled study
Study objectives	The primary objective of this study is to evaluate the efficacy of the product in reducing hair shedding by phototricogram using TrichoScan in female and male subjects showing acute telogen effluvium, in particular, monitoring the efficacy of the tested product in modulating the anagen/telogen distribution compared to placebo. The secondary objectives of this study is to evaluate the efficacy of the product in improving hair conditions and investigate the pleasantness of the product perceived by the subjects.
Ethics approval(s)	Approved 27/03/2026, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), Lain, 20045, Italy; +39 3783037302; secretariat@ieicomittee.com), ref: Rif. IC0020 A
Health condition(s) or problem(s) studied	Transient acute telogen effluvium
Intervention	The active intervention is a multi-active topical scalp serum containing peptides, plant extracts, caffeine, niacinamide and other functional actives, whereas the placebo consists of the same vehicle formulation devoid of these active ingredients. A restricted randomization list will be generated by an independent technician using the appropriate algorithm ("Wei’surn") 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: apply daily to dry or damp hair. Divide the hair into four sections and distribute one full dropper for each section directly onto the scalp. Gently massage until fully absorbed. Do not rinse. Clinical visits are planned at T0 (Initial visit), T2 (follow-up visit, after 56 ± 2 days of product use) and at T3 (final visit, after 84 ± 2 days of product use).
Intervention type	Other
Primary outcome measure(s)	Improvement in hair density measured using TrichoScan® supplier and software at baseline (T0), T2 and T3 Improvement in anagen and telogen hair (%) measured using TrichoScan® supplier and software at baseline (T0), T2 and T3 Improvement in anagen/telogen ratio measured using TrichoScan® supplier and software at baseline (T0), T2 and T3
Key secondary outcome measure(s)	Efficacy perceived and the pleasantness of the product measured using self-evaluation questionnaire (polytomous question with four possible answers) at T3
Completion date	04/09/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	44
Key inclusion criteria	1. Healthy female (60%) and male (40%) subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 60 years (extremes included) 4. Subjects with transient acute telogen effluvium (duration less than 6 months) due to fatigue, seasonal change, deficiency of vitamins and minerals, stress, change or imbalance of normal daily routing, or emotional stress* 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 one 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 At the recruitment * Subjects are asked not to change their usual
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 intolerances or 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	30/03/2026
Date of final enrolment	08/05/2026

Locations

Countries of recruitment

Italy
Romania

Study participating centres

Complife Italia SRL

Via Fratelli Signorelli 159
Garbagnate MIlanese
20024
Italy

Complife Italia SRL

Via Monsignor Angelini 21
San Martino Siccomario
27028
Italy

Nutratech SRL

via F. Todaro 20/22
Rende
87036
Italy

Complife Romania SRL

Strada Orzari 92A
București
021554
Romania

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	version 00	13/03/2026	07/05/2026	No	No

Additional files

49486 PROTOCOL_EC_000020026_V00 13Mar2026.pdf: Protocol file

Editorial Notes

07/05/2026: Trial's existence confirmed by International Ethics and Integrity Committee.