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

Primary Purpose

Sensitive Skin

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
P926 - LICHTENA DermAD CREMA VISO
P927 - LICHTENA DermAD CREMA CORPO
P926 - LICHTENA DermAD CREMA VISO - PLACEBO
Untreated control area
Sponsored by
Derming SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensitive Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • DERMING

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LICHTENA DermAD

Arm 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)

Outcomes

Primary Outcome Measures

Change from baseline of skin erythema index
The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)
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®)
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.
Change from baseline of Superficial skin hydration
Skin electrical capacitance value is measured with Corneometer CM825
Change from baseline of deep skin hydration
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Change from baseline of Epicutaneous pH
Surface cutaneous pH is measured with pH meter HI5221
Change from baseline of Surface microrelief's regularity
Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable

Secondary Outcome Measures

Full Information

First Posted
March 8, 2018
Last Updated
March 26, 2018
Sponsor
Derming SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03464890
Brief Title
Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
Official Title
Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
February 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derming SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitive Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LICHTENA DermAD
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
P926 - LICHTENA DermAD CREMA VISO
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
P927 - LICHTENA DermAD CREMA CORPO
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
P926 - LICHTENA DermAD CREMA VISO - PLACEBO
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Untreated control area
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of skin erythema index
Description
The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)
Time Frame
Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Title
Change from baseline of skin redness
Description
The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®)
Time Frame
Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Title
Change from baseline of Transepidermal water loss (TEWL)
Description
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.
Time Frame
Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Title
Change from baseline of Superficial skin hydration
Description
Skin electrical capacitance value is measured with Corneometer CM825
Time Frame
Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Title
Change from baseline of deep skin hydration
Description
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Time Frame
Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Title
Change from baseline of Epicutaneous pH
Description
Surface cutaneous pH is measured with pH meter HI5221
Time Frame
Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Title
Change from baseline of Surface microrelief's regularity
Description
Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable
Time Frame
Baseline (T0), 1 hour (T1h), 24 hours (T24h)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
DERMING
City
Milano
State/Province
MI
ZIP/Postal Code
20149
Country
Italy

12. IPD Sharing Statement

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

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