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

NCT03464890 | Completed

• 1 other identifier: E2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensitive Skin

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (1)

LICHTENA DermAD

EXPERIMENTAL

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

Interventions

P926 - LICHTENA DermAD CREMA VISO OTHER

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.

LICHTENA DermAD

P927 - LICHTENA DermAD CREMA CORPO OTHER

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.

LICHTENA DermAD

P926 - LICHTENA DermAD CREMA VISO - PLACEBO OTHER

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.

LICHTENA DermAD

Untreated control area OTHER

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.

LICHTENA DermAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20149, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: January 22, 2018
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

IT (1)