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Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin

Primary Purpose

Atopic Dermatitis

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

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult volunteers of both sexes
  • volunteers with positive anamnesis for atopy and habitual itching
  • volunteers in a good general state of health in the Investigator opinion
  • negative pregnancy test (only for female subjects not in menopause)
  • accepting to follow the instructions received by the investigator
  • accepting to not change their habits regarding food, physical activity, body cleansing
  • agreeing not to apply or take any product/drug or use body massages able to change skin conditions during the entire duration of the study
  • accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study
  • no participation in a similar study currently or during the previous 3 months
  • volunteers who are giving a written informed consent.

Exclusion Criteria:

  • Pregnancy (only for female subjects not in menopause)
  • lactation (only for female subjects not in menopause)
  • change in the normal habits in the last month
  • participation in a similar study during the previous 3 months
  • known allergy to one or several ingredients of the product on trial
  • insufficient adhesion to the study protocol
  • 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

P927 - LICHTENA DermAD CREMA CORPO

Arm Description

Application of the product under study mono-laterally at level of the forearm, including the antecubital fold, on the right or left side according to a randomization list defined by the investigator.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline of itching sensation
Each volunteers scored its own itching sensation thanks to a visual analogic scale (VAS from 0 = no itching to 10= strong itching).

Full Information

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

Unique Protocol Identification Number
NCT03484897
Brief Title
Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
Official Title
Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
March 20, 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 activity of a body cream to be applied once a day, mono-laterally at level of the antecubital fold and forearm, for an uninterrupted period of 1 month, by 22 adult volunteers, with positive anamnesis for atopy and habitual itching.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
P927 - LICHTENA DermAD CREMA CORPO
Arm Type
Experimental
Arm Description
Application of the product under study mono-laterally at level of the forearm, including the antecubital fold, on the right or left side according to a randomization list defined by the investigator.
Intervention Type
Other
Intervention Name(s)
P927 - LICHTENA DermAD CREMA CORPO
Intervention Description
The study cream was applied once a day (at the morning or at the evening), preferentially always at the same hour, with a mild massage, for an uninterrupted period of 1 month
Primary Outcome Measure Information:
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 month (T1), 2 months (T2)
Title
Change from baseline of Superficial skin hydration
Description
Skin electrical capacitance value is measured with Corneometer CM825
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2)
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 month (T1), 2 months (T2)
Title
Change from baseline of Epicutaneous pH
Description
Surface cutaneous pH is measured with pH meter HI5221
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2)
Title
Change from baseline of Surface microrelief's regularity
Description
Surface microrelief's regularity is performed on skin replicas images acquired by Primos
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2)
Secondary Outcome Measure Information:
Title
Change from baseline of itching sensation
Description
Each volunteers scored its own itching sensation thanks to a visual analogic scale (VAS from 0 = no itching to 10= strong itching).
Time Frame
Baseline (T0), 1 month (T1), 2 months (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult volunteers of both sexes volunteers with positive anamnesis for atopy and habitual itching volunteers in a good general state of health in the Investigator opinion negative pregnancy test (only for female subjects not in menopause) accepting to follow the instructions received by the investigator accepting to not change their habits regarding food, physical activity, body cleansing agreeing not to apply or take any product/drug or use body massages able to change skin conditions during the entire duration of the study accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study no participation in a similar study currently or during the previous 3 months volunteers who are giving a written informed consent. Exclusion Criteria: Pregnancy (only for female subjects not in menopause) lactation (only for female subjects not in menopause) change in the normal habits in the last month participation in a similar study during the previous 3 months known allergy to one or several ingredients of the product on trial insufficient adhesion to the study protocol 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 Barrier Restoration Activity of a Body Cream for Atopic Skin

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