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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P927 - LICHTENA DermAD CREMA CORPO | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P927 - LICHTENA DermAD CREMA CORPO | Other | 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 |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DERMING | Milan | MI | 20149 | Italy |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |