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

Not Applicable

Completed

• Conditions: Sensitive Skin
• Interventions: Other: P926 - LICHTENA DermAD CREMA VISO; Other: P927 - LICHTENA DermAD CREMA CORPO; Other: P926 - LICHTENA DermAD CREMA VISO - PLACEBO; Other: Untreated control area

• Registration Number: NCT03464890
• Lead Sponsor: Derming SRL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Primary Completion: 2018-02-13
• Study Completion: 2018-02-13
• Status Verified: 2018-03
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-14
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LICHTENA DermAD	P926 - LICHTENA DermAD CREMA VISO - PLACEBO	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)
LICHTENA DermAD	P927 - LICHTENA DermAD CREMA CORPO	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)
LICHTENA DermAD	Untreated control area	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)
LICHTENA DermAD	P926 - LICHTENA DermAD CREMA VISO	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)

Primary Outcome Measures

Name	Time	Method
Change from baseline of skin erythema index	Baseline (T0), 1 hour (T1h), 24 hours (T24h)	The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)
Change from baseline of skin redness	Baseline (T0), 1 hour (T1h), 24 hours (T24h)	The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®)
Change from baseline of Transepidermal water loss (TEWL)	Baseline (T0), 1 hour (T1h), 24 hours (T24h)	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.
Change from baseline of Superficial skin hydration	Baseline (T0), 1 hour (T1h), 24 hours (T24h)	Skin electrical capacitance value is measured with Corneometer CM825
Change from baseline of deep skin hydration	Baseline (T0), 1 hour (T1h), 24 hours (T24h)	Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Change from baseline of Epicutaneous pH	Baseline (T0), 1 hour (T1h), 24 hours (T24h)	Surface cutaneous pH is measured with pH meter HI5221
Change from baseline of Surface microrelief's regularity	Baseline (T0), 1 hour (T1h), 24 hours (T24h)	Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable

Trial Locations

Locations (1)

DERMING; 🇮🇹 Milano, MI, Italy