Clinical study for the evaluation of the anti-ageing properties of a food supplement

ISRCTN	ISRCTN67914056
DOI	https://doi.org/10.1186/ISRCTN67914056
Study code	IT0008187b/25
Sponsor	SAS COPALIS Industrie
Funder	SAS COPALIS Industrie

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

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

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 Gloria Roveda
Principal investigator

Via Mons. Angelini, 21
San Martino Siccomario
27028
Italy

Phone	+39 0382 490286
Email	info@complifegroup.com

Dr Francesca De Gennaro
Scientific, Public

Via Mons. Angelini, 21
San Martino Siccomario
27028
Italy

Phone	+39 0382 25504
Email	francesca.degennaro@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 study for the evaluation of the antiageing properties of a food supplement. Controlled study vs placebo
Study objectives	The study aims to assess the efficacy of a food supplement, in improving skin conditions. In particular, the supplement’s anti-aging efficacy and its overall benefits on skin health will be investigated by evaluating skin elasticity, firmness, profilometry (wrinkle depth), skin moisturization, skin radiance and skin fiber structure (dermis and epidermis). Objective and subjective assessments of product efficacy will be also assessed through self-assessment questionnaires.
Ethics approval(s)	Approved 08/04/2026, International Ethics and Integrity Committee (IEIC) (Via Per Garbagnate 61, Lainate, 20045, Italy; +39 3783037302; secretariat@ieicomittee.com), ref: IC009A
Health condition(s) or problem(s) studied	Healthy subjects with phototype II-IV (according to Fitzpatrick scale), presenting visible Crow’s feet wrinkles, moderate skin slackness and dull complexion .
Intervention	The active intervention is a food supplement containing Prolastine, while the placebo contains the same excipients without the active ingredient. 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 take the assigned treatment for 84 days ± 2 days as follows: two capsules per day in the morning, with a glass of water, during breakfast.
Intervention type	Supplement
Primary outcome measure(s)	Skin elasticity and firmness measured using a cutometer at baseline and after 28 and 84 days Wrinkle depth measured using Primos 3D at baseline and after 28 and 84 days Skin smoothness (Ra parameter) measured using Primos 3D at baseline and after 28 and 84 days Skin moisturization measured using a corneometer at baseline and after 28 and 84 days Skin radiance (gloss parameter) measured using a spectrophotometer/colorimeter CM 700D at baseline and after 28 and 84 day Skin wrinkledness, tonicity, moisturization and radiance measured using clinical internal scales at baseline and after 28 and 84 day
Key secondary outcome measure(s)	Dermal fibres analysis measured using line-field confocal optical coherence tomography (LC-OCT) at baseline and after 84 days Efficacy perceived and the pleasantness of the product measured using a self-evaluation questionnaire at 28 and 84 days
Completion date	21/08/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	45 Years
Upper age limit	65 Years
Sex	Female
Target sample size at registration	66
Total final enrolment	66
Key inclusion criteria	1. Good general health 2. Caucasian ethnicity 3. Female sex 4. Age between 45 and 65 years old (extremes included) 5. Subjects with subjects with phototype II-IV (according to Fitzpatrick scale) 6. Subjects presenting visible Crow’s feet wrinkles, moderate skin slackness and dull complexion 7. Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the experimenter but at least 1 month must be elapsed between a previous study on food supplement) 8. Subjects registered with health social security or health social insurance 9. Subjects having signed their written the Informed Consent Form (ICF) and Privacy Policy for their participation in the study 10. Subjects able to understand the language used in the investigation centre and the information given 11. Subjects able to comply with the protocol and follow protocol constraints and specific requirements 12. Willingness to intake during all the study period only the product to be tested 13. Willingness not to use similar products that could interfere with the product to be tested (e.g. antiaging oral/topic products) 14. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.) 15. Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial 16. Willingness to avoid direct sun to face during the duration of experiment 17. Willingness to not use tanning beds or other light therapies to face for duration of experiment 18. Willingness to no use of fillers, botox, or lasers during experiment
Key exclusion criteria	1. Subjects who do not meet the inclusion criteria 2. Subject is taking part or planning to participate to another clinical study in the same or in another investigation centre 3. Subject who is deprived of freedom by administrative or legal decision or under guardianship 4. Subject admitted in a sanitary or social facilities 5. Subject who is planning an hospitalization during the study 6. Subjects under treatment with food supplements which could interfere with the functionality of the product under study (e.g., supplements containing collagen peptides, hyaluronic acid, antioxidants compound or anti-inflammatory botanical extracts) 7. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential) 8. Subject has started or changed estrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study 9. Subject having an acute, chronic or progressive diseases (e.g. sever atopic dermatitis, psoriasis) liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 10. Subjects under radiotherapy, chemotherapy at any time 11. Subject having a skin condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 12. Pharmacological treatments (topic or systemic) known to interfere with skin metabolism/physiology 13. Subjects under locally pharmacological/non-pharmacological treatment applied on the skin area monitored during the test 14. Subject with known or suspected sensitization to one or more test formulation ingredients 15. Subjects considered as not adequate to participate to the study by the investigator 16. Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated) 17. Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function. 18. Subjects who have used tanning beds or direct sun to the face in the previous 4 weeks 19. Subjects who have used fillers or botox to facial areas in the past 4 or 6 months
Date of first enrolment	13/04/2026
Date of final enrolment	08/05/2026

Locations

Countries of recruitment

France
Italy

Study participating centres

Complife Italia S.r.l.

Via Monsignor Angelini, 21
San Martino Siccomario
27028
Italy

Complife Italia S.r.l.

Corso San Maurizio 25
Biella
13900
Italy

Complife Italia S.r.l.

Via Signorelli, 159
Garbagnate Milanese
20024
Italy

Complife France - Le Quadrille

18 Rue Jaqueline Auriol
Lyon
69008
France

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 1.0	16/03/2026	07/07/2026	No	No

Additional files

49858_Protocol_v1.0_16March2026.pdf: Protocol file

Editorial Notes

07/07/2026: Study’s existence confirmed by the International Ethics and Integrity Committee (IEIC), Italy.