Clinical-instrumental evaluation of the efficacy of a cosmetic product for subjects with atopic dermatitis

ISRCTN	ISRCTN95276136
DOI	https://doi.org/10.1186/ISRCTN95276136
Protocol Number	PIT0000216/25_Rev.02
Study Code_Order	H.E.HU.AD.NSO05.020.11.00_IT0000467/26
Sponsor	OMEIA SA
Funder	OMEIA SA

Submission date: 31/08/2026
Registration date: 23/09/2026
Last edited: 15/09/2026

Recruitment status: No longer recruiting
Overall study status: Completed
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 Sabrina Ghirlanda
Public, Scientific

Complife Italia S.r.l., Corso San Maurizio, 25
Biella
13900
Italy

Phone	+39 02 99025138
Email	sabrina.ghirlanda@complifegroup.com

Dr Enza Cestone
Principal investigator

Complife Italia S.r.l., Via Angelini 21
S. Martino Siccomario (PV)
27028
Italy

Phone	+39 (0)38225504
Email	info@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	Placebo-controlled clinical-instrumental evaluation of the efficacy of a cosmetic product for subjects with atopic dermatitis
Study objectives	To evaluate the efficacy of a cosmetic product in improving skin discomfort and clinical signs (such as dryness, desquamation, erythema, and itching) in subjects with mild to moderate atopic dermatitis
Ethics approval(s)	Ethics approval not required
Health condition(s) or problem(s) studied	Healthy subjects with atopic dermatitis
Intervention	The investigational product is JP_25_006, containing aqua, cetearyl alcohol, ethylhexyl laurate, glycerin, ceteareth-20, clay, citric acid, potassium sorbate. The placebo contains aqua, cetearyl alcohol, ethylhexyl laurate, glycerin, ceteareth-20, citric acid, potassium sorbate. Half of the recruited subjects are randomized to receive the active product, while the other half receive the placebo. The principal investigator or a designated delegate dispenses the investigational products according to the randomization list. The study is conducted as a double-blind trial: subjects, investigators, and collaborators are blinded to product allocation. Both the active and placebo products are provided in identical packaging, with no distinguishable differences between them. The study foresees 28 days of product use. Evaluations are performed before (T0), immediately after product application (Timm) and after 7 (T7) and 28 (T28) days of use. The product is applied onto the affected area for 28 consecutive days.
Intervention type	Other
Primary outcome measure(s)	Skin moisturization measured using a Corneometer®, which measures changes in capacitance related to the water content of the superficial skin layer (approximately 10–20 μm) at T0, T7, T28 Transepidermal water loss (TEWL) measured using Tewameter 300® (Courage+Khazaka electronic GmbH), based on the TEWAMETER® method. TEWL quantifies the rate of water loss through the skin and is expressed as g/m²/h at T0, T7, T28 Assessment of SCORAD clinical scoring by the dermatologist measured using the SCORAD software (version 5.0), based on the assessment of the extent and intensity of atopic dermatitis and subjective symptoms (pruritus and sleep loss) at T0, T7, T28 Assessment of PO-SCORAD by the subject measured using he PO-SCORAD software (version 5.0), based on the subject’s assessment of the extent and intensity of atopic dermatitis and subjective symptoms (pruritus and insomnia) at T0, T7, T28 LC-OCT on 22 subjects measured using Line-field Confocal Optical Coherence Tomography (LC-OCT) with 3D vertical stacks and isotropic cellular resolution at T0,T28
Key secondary outcome measure(s)	Self-evaluation during application (Timm) measured using a subject-reported discomfort score during the first product application at T0 Self-assessment questionnaire measured using a subject-reported questionnaire evaluating the subjects’ perception and opinion of the tested products at T0,T7,T28 Quality of life measured using a modified quality of life questionnaire completed by subjects before product use and at the end of the study at T0,T28
Completion date	30/04/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	88
Total final enrolment	88
Key inclusion criteria	1. Healthy female and male subjects (with no specific repartition) 2. Aged over 18 years 3. Caucasian ethnicity 4. Subjects showing clinical signs and skin discomforts typical of mild to moderate atopic dermatitis on the face and/or body, with skin characterised by dryness, desquamation, erythema and itching symptoms (mild to moderate severity; SCORAD score between 15 and 40) 5. Subjects registered with the National Health Service 6. Subjects certifying the truthfulness of the personal data disclosed to the investigator 7. Subjects able to understand the language used in the investigation centre and the information provided by the investigator 8. Subjects able to follow the investigator's instructions and comply with the study constraints and specific requirements 9. Pharmacological therapy (except for therapies specified in the non-inclusion criteria) stable for at least 1 month, with no changes expected or planned during the study 10. Willingness not to use products likely to interfere with the product being tested 11. Commitment not to change daily routine or lifestyle during the study 12. Subjects who have signed an informed consent form
Key exclusion criteria	1. Subject not satisfying the inclusion criteria 2. Subjects with acute or chronic diseases that may interfere with the study outcomes or are considered dangerous for the subject or incompatible with the study requirements 3. Subjects participating in, or planning to participate in, other clinical trials 4. Subjects deprived of freedom by administrative or legal decision, or under guardianship 5. Subjects who cannot be contacted in case of emergency 6. Subjects planning hospitalisation during the study period 7. Subjects admitted to a health or social care facility 8. Subjects who have participated in a similar study without observing an adequate washout period 9. Subjects with an acute, chronic or progressive illness that may interfere with study data or is considered by the investigator to be hazardous for the subject or incompatible with the study requirements 10. Subjects receiving pharmacological treatment that is incompatible with the study requirements 11. Subjects with a skin disease or condition that may interfere with study data or is considered by the investigator to be hazardous for the subject or incompatible with the study requirements 12. Subjects with known allergies to cosmetic products, toiletries, medications, patches or cosmetic devices 13. Women who are breastfeeding, pregnant, or unwilling to take the necessary precautions to avoid pregnancy during the study (if of childbearing potential)
Date of first enrolment	25/02/2026
Date of final enrolment	10/04/2026

Locations

Countries of recruitment

Georgia
Italy
Romania

Study participating centres

Complife Italia SRL

Piazzale Siena 11
Milano
20146
Italy

Complife Italia SRL

Via Angelini 21
S. Martino Siccomario (PV)
27028
Italy

Complife Italia SRL

Via Fratelli Signorelli 159
Garbagnate Milanese
20024
Italy

Complife Italia SRL

Corso San Maurizio, 25
Biella
13900
Italy

Nutratech SRL

Via Francesco Todaro 20/22
Rende
87036
Italy

Complife Romania SRL

Strada Orzari 92A
București
021554
Romania

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	version 2	30/12/2025	01/09/2026	No	No

Additional files

50195 PROTOCOL_ATOPIC.SKIN v2 30Dec2025.pdf: Protocol file

Editorial Notes

15/09/2026: Trial's existence confirmed by Complife.