Dry SkinNCT07393191
Evaluation of Hydrating Cream Effect on Subjects With Dry Skin.
A study testing Repairing cream in people with Dry Skin and Sensitive Skin, run by Lacer S.A. at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Skin, Sensitive Skin, Cracked Skin
- What is being tested?
- Repairing cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2024to 16 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Dry Skin, Sensitive Skin, Cracked Skin
- Being tested
- Repairing cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repairing creamOther
The cream was applied twice a day for 1 month
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Repairing cream |
| Untreated | No intervention | No product application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 a questionnaire with questions regarding acceptability and subjective efficacy of the product. The outcome measurement was the % of the agreement with the question.
Measured: Subjects responded to questionnaires at 30min, 24 hours, 48 hours, 7 days and 28 days of product use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start17 Dec 2024
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects applied the product on one leg, while the other leg was used as control (without product application).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lacer S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enza Cestone, Principal investigator, Complife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393191
- Sponsor's protocol ID
- IT0007726/24
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary of the results to support the publication will be shared. No complete study documents will shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Instrumental Evaluation of the Efficacy of a Cosmetic Product in Improving Skin Moisturization and Skin Barrier
- ClinicalTrials.gov ID
- NCT07393191
- Acronym / sponsor ID
- IT0007726/24
- Conditions
- Dry Skin, Sensitive Skin, Cracked Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lacer S.A.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects applied the product on one leg, while the other leg was used as control (without product application).
| Arm | Type | Receives |
|---|---|---|
| subjects applied tested product on one leg and the other leg was left untreated (control) | Experimental | Other: Repairing creamSubjects 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. |
| Untreated | No intervention | –No product application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repairing creamThe cream was applied twice a day for 1 month | Other | subjects applied tested product on one leg and the other leg was left untreated (control) |
Primary outcome
Change in skin moisturization from baseline to 28 days
Time frame: Change from baseline in skin hydration at 30min, 24 hours, 48 hours, 7 days and 28 days.
Skin hydration defined as skin capacitance value measured by Corneometer. Higher value means more hydrated skin.
Change in skin barrier function from baseline to 28 days
Time frame: Change from baseline in skin barrier function at 30min, 24 hours, 48 hours, 7 days and 28 days.
Skin barrier function defined as transepidermal water loss value measured by Tewameter. Lower value means improved skin barrier function.
1 secondary outcome
Assessment of product acceptability
Time frame: Subjects responded to questionnaires at 30min, 24 hours, 48 hours, 7 days and 28 days of product use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No. Only summary of the results to support the publication will be shared. No complete study documents will shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enza Cestone principal investigator
Complife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repairing cream in people with Dry Skin and Sensitive Skin, run by Lacer S.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin moisturization from baseline to 28 days (time frame: Change from baseline in skin hydration at 30min, 24 hours, 48 hours, 7 days and 28 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.