An interventional study of P926 - LICHTENA DermAD CREMA VISO and P927 - LICHTENA DermAD CREMA CORPO in Sensitive Skin, sponsored by Derming SRL. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by Derming SRL · Not applicable, Interventional, and Treatment
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.
Derming SRL is the lead sponsor of 26 studies on the registry; none are open to participants now.
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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)
Other: P926 - LICHTENA DermAD CREMA VISO · Other: P927 - LICHTENA DermAD CREMA CORPO · Other: P926 - LICHTENA DermAD CREMA VISO - PLACEBO · Other: Untreated control area
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.
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.
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.
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.
Change from baseline of skin erythema index
The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)
Time frame: 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®)
Time frame: 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.
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Change from baseline of Superficial skin hydration
Skin electrical capacitance value is measured with Corneometer CM825
Time frame: 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
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Change from baseline of Epicutaneous pH
Surface cutaneous pH is measured with pH meter HI5221
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Change from baseline of Surface microrelief's regularity
Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Ran from Jan 2018 to primary completion in Feb 2018, 0 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Derming SRL