Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
NCT ID: NCT03464890
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-01-22
2018-02-13
Brief Summary
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Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LICHTENA DermAD
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)
P926 - LICHTENA DermAD CREMA VISO
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.
P927 - LICHTENA DermAD CREMA CORPO
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.
P926 - LICHTENA DermAD CREMA VISO - PLACEBO
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 control area
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.
Interventions
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P926 - LICHTENA DermAD CREMA VISO
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.
P927 - LICHTENA DermAD CREMA CORPO
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.
P926 - LICHTENA DermAD CREMA VISO - PLACEBO
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 control area
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.
Eligibility Criteria
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Inclusion Criteria
* TEWL value on tested skin areas immediately after tape stripping \>15g/m2-h
* volunteers in a good general state of health in the Investigator opinion
* volunteers not taking drugs or undergoing surgical procedure
* volunteers who are giving a written informed consent.
Exclusion Criteria
* lactation (only for female subjects)
* TEWL value on tested skin areas immediately after tape stripping \<15g/m2-h
* change in the normal habits in the last month
* participation in a similar study during the previous month
* known allergy to one or several ingredients of the products on trial.
* 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.
18 Years
ALL
Yes
Sponsors
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Derming SRL
OTHER
Responsible Party
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Adele Sparavigna
Medical Doctor
Locations
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DERMING
Milan, MI, Italy
Countries
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Other Identifiers
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E2017
Identifier Type: -
Identifier Source: org_study_id
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