Evaluation of Hydrating Cream Effect on Subjects With Dry Skin.

NCT07393191 | Completed

• 1 other identifier: IT0007726/24
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Skin; Sensitive Skin; Cracked Skin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of product acceptability

  Subjects responded to questionnaires at 30min, 24 hours, 48 hours, 7 days and 28 days of product use.

Study Arms (2)

subjects applied tested product on one leg and the other leg was left untreated (control)

EXPERIMENTAL

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

Untreated

NO INTERVENTION

No product application

Interventions

Repairing cream OTHER

The cream was applied twice a day for 1 month

subjects applied tested product on one leg and the other leg was left untreated (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Commitment not to change the daily routine or the lifestyle
• Subject informed about the study procedures and having signed the privacy policy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lacer S.A.: lead

Study Sites (1)

Complife Italia

San Martino Siccomario, Milano, 27028, Italy

Location

Study Officials

• Enza Cestone

  Complife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects applied the product on one leg, while the other leg was used as control (without product application).

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 6, 2026
• Study Start: December 17, 2024
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)