Evaluation of Hydrating Cream Effect on Subjects With Dry... | NCT07393191

NCT07393191

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Eligibility Criteria

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)