Evaluation of Hydrating Cream Effect on Subjects With Dry Skin.

Clinical Instrumental Evaluation of the Efficacy of a Cosmetic Product in Improving Skin Moisturization and Skin Barrier

The goal of this clinical trial is to learn if a cosmetic product works to improve skin condition in adults with dry, very dry, sensitive and cracked skin showing discomfort. The main questions it aims to answer are:

• Does the cosmetic increase skin hydration and skin barrier function?
• Does the cosmetic improve skin discomfort signs? Researchers will compare the skin condition with and without product use to see if it works to improve dry, sensitive and cracked skin.

Participants will:

• Use cosmetic twice a day for 1 month
• Visit the research center on day 1, 2, 7 and 28 of product use for evaluations

Study Overview

• Status: Completed
• Conditions: Dry Skin; Sensitive Skin; Cracked Skin
• Intervention / Treatment: Other: Repairing cream

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano
    • San Martino Siccomario, Milano, Italy, 27028
      • Complife Italia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy female and male subjects (without specific repartition)
• Caucasian ethnicity
• Aged between 18 and 65 years old
• Subjects with dry (<30 c.u.), very dry (<25 c.u.), sensitive and cracked skin
• Subjects must show all the listed skin discomforts (skin dryness, desquamation, skin tightness, and itching
• Subjects aware of the study procedures and having signed an informed consent form
• Subjects registered with National Health Service (NHS)
• Subjects certifying the truthfulness of the personal data disclosed to the investigator
• Subjects able to understand the language used in the investigation and to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
• The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
• Commitment not to change the daily routine or the lifestyle
• Subject informed about the study procedures and having signed the privacy policy

Exclusion Criteria:

• Subjects who do not fit the inclusion criteria.
• Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
• Subjects participating or planning to participate in other clinical trials
• Subjects deprived of freedom by administrative or legal decision or under guardianship
• Subjects not able to be contacted in case of emergency
• Subjects admitted to a health or social facility
• Subjects planning a hospitalization during the study
• Subjects who participated in a similar study without respecting an adequate washout period (14 days)
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
• Cosmetic treatment known to interfere with the tested product (e.g.: laser, peeling)
• Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
• Subjects intolerant or allergic to one or more ingredients of the cosmetic product
• Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
• Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: subjects applied tested product on one leg and the other leg was left untreated (control); Subjects applied tested product on right or left leg (as per randomization) and the other leg was left untreated and acted as control area. The product was applied twice a day during 1 month.	Other: Repairing cream; The cream was applied twice a day for 1 month
No Intervention: Untreated; No product application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in skin moisturization from baseline to 28 days	Skin hydration defined as skin capacitance value measured by Corneometer. Higher value means more hydrated skin.	Change from baseline in skin hydration at 30min, 24 hours, 48 hours, 7 days and 28 days.
Change in skin barrier function from baseline to 28 days	Skin barrier function defined as transepidermal water loss value measured by Tewameter. Lower value means improved skin barrier function.	Change from baseline in skin barrier function at 30min, 24 hours, 48 hours, 7 days and 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of product acceptability	Subjects responded a questionnaire with questions regarding acceptability and subjective efficacy of the product. The outcome measurement was the % of the agreement with the question.	Subjects responded to questionnaires at 30min, 24 hours, 48 hours, 7 days and 28 days of product use.

Collaborators and Investigators

• Sponsor: Lacer S.A.
• Investigators: Principal Investigator: Enza Cestone, Complife

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Actual): April 16, 2025
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IT0007726/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only summary of the results to support the publication will be shared. No complete study documents will shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No