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

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.

Study Overview

• Status: Completed
• Conditions: Sensitive Skin
• Intervention / Treatment: Other: P926 - LICHTENA DermAD CREMA VISO; Other: P927 - LICHTENA DermAD CREMA CORPO; Other: P926 - LICHTENA DermAD CREMA VISO - PLACEBO; Other: Untreated control area

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20149
      • DERMING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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)

Other: 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.; Other: 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.; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable	Baseline (T0), 1 hour (T1h), 24 hours (T24h)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): February 13, 2018
• Study Completion (Actual): February 13, 2018

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: E2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No