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Open clinical study to evaluate the soothing and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers.
Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LICHTENA DermAD | Experimental | Comparison within subjects of "P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO" versus placebo and versus untreated control area. Study products were applied once, on experimentally induced erythema by repeated tape stripping on 4 different adjacent skin areas of the forearms (volar surface - 2 areas on each side) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P926 - LICHTENA DermAD CREMA VISO | Other | The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of skin erythema index | The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404) | Baseline (T0), 1 hour (T1h), 24 hours (T24h) |
| Change from baseline of skin redness | The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®) | Baseline (T0), 1 hour (T1h), 24 hours (T24h) |
| 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 hour (T1h), 24 hours (T24h) |
| Change from baseline of Superficial skin hydration | Skin electrical capacitance value is measured with Corneometer CM825 | Baseline (T0), 1 hour (T1h), 24 hours (T24h) |
| Change from baseline of deep skin hydration | Tissue dielectric constant of deep skin layers is measured with MoistureMeterD | Baseline (T0), 1 hour (T1h), 24 hours (T24h) |
| Change from baseline of Epicutaneous pH | Surface cutaneous pH is measured with pH meter HI5221 | Baseline (T0), 1 hour (T1h), 24 hours (T24h) |
| Change from baseline of Surface microrelief's regularity |
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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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| P927 - LICHTENA DermAD CREMA CORPO | Other | The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. |
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| P926 - LICHTENA DermAD CREMA VISO - PLACEBO | Other | The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. |
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| Untreated control area | Other | Untreated skin area of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. |
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Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable
| Baseline (T0), 1 hour (T1h), 24 hours (T24h) |