Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area

Derming

Status: Completed

Conditions: Sensitive Skin

Treatments: Other: Untreated control area; Other: P926 - LICHTENA DermAD CREMA VISO; Other: P926 - LICHTENA DermAD CREMA VISO - PLACEBO; Other: P927 - LICHTENA DermAD CREMA CORPO

Study type: Interventional

Funder types: Other

Identifiers

NCT03464890

E2017

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Volunteers of both sexes
• 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

• Pregnancy (only for female subjects)
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

LICHTENA DermAD

Experimental group

Description:

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)

Treatment:

Other: P927 - LICHTENA DermAD CREMA CORPO

Other: Untreated control area

Other: P926 - LICHTENA DermAD CREMA VISO

Other: P926 - LICHTENA DermAD CREMA VISO - PLACEBO