Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin

Study Overview
=================
Brief Summary
-----------------
Open clinical study to evaluate the soothing activity of a body cream to be applied once a day, mono-laterally at level of the antecubital fold and forearm, for an uninterrupted period of 1 month, by 22 adult volunteers, with positive anamnesis for atopy and habitual itching.

Official Title
-----------------
Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: P927 - LICHTENA DermAD CREMA CORPO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult volunteers of both sexes volunteers with positive anamnesis for atopy and habitual itching volunteers in a good general state of health in the Investigator opinion negative pregnancy test (only for female subjects not in menopause) accepting to follow the instructions received by the investigator accepting to not change their habits regarding food, physical activity, body cleansing agreeing not to apply or take any product/drug or use body massages able to change skin conditions during the entire duration of the study accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study no participation in a similar study currently or during the previous 3 months volunteers who are giving a written informed consent. Exclusion Criteria: Pregnancy (only for female subjects not in menopause) lactation (only for female subjects not in menopause) change in the normal habits in the last month participation in a similar study during the previous 3 months known allergy to one or several ingredients of the product on trial insufficient adhesion to the study protocol Dermatitis presence of cutaneous disease on the tested area, as lesions, scars, malformations clinical and significant skin condition on the test area. Diabetes endocrine disease hepatic disorder renal disorder cardiac disorder pulmonary disease cancer neurological or psychological disease inflammatory/immunosuppressive disease drug allergy. Anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago) using of drugs able to influence the test results in the investigator opinion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P927 - LICHTENA DermAD CREMA CORPO<br>Application of the product under study mono-laterally at level of the forearm, including the antecubital fold, on the right or left side according to a randomization list defined by the investigator. | Other: P927 - LICHTENA DermAD CREMA CORPO<br>* The study cream was applied once a day (at the morning or at the evening), preferentially always at the same hour, with a mild massage, for an uninterrupted period of 1 month<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Transepidermal water loss (TEWL) | The measurement of TEWL, performed by the use of Tewameter® TM300, allows to objectively monitor skin responses to cosmetic treatments. A shift from low-normal rates of TEWL to high levels is due to barrier disruption. | Baseline (T0), 1 month (T1), 2 months (T2) | 
| Change from baseline of Superficial skin hydration | Skin electrical capacitance value is measured with Corneometer CM825 | Baseline (T0), 1 month (T1), 2 months (T2) | 
| Change from baseline of Deep skin hydration | Tissue dielectric constant of deep skin layers is measured with MoistureMeterD | Baseline (T0), 1 month (T1), 2 months (T2) | 
| Change from baseline of Epicutaneous pH | Surface cutaneous pH is measured with pH meter HI5221 | Baseline (T0), 1 month (T1), 2 months (T2) | 
| Change from baseline of Surface microrelief's regularity | Surface microrelief's regularity is performed on skin replicas images acquired by Primos | Baseline (T0), 1 month (T1), 2 months (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of itching sensation | Each volunteers scored its own itching sensation thanks to a visual analogic scale (VAS from 0 = no itching to 10= strong itching). | Baseline (T0), 1 month (T1), 2 months (T2) |