Effect of Ectoin Dermatitis Cream 7% on Skin Hydration and Skin Barrier Function

January 8, 2020 updated by: Bitop AG

Effect of Ectoin Dermatitis Cream 7% (EHK02) on Skin Hydration and Skin Barrier Function in Patients With Atopic Dermatitis: a Prospective, Clinical Study

The aim of this prospective, uncontrolled clinical study is to evaluate the clinical effect of Ectoin® Dermatitis Cream-EHK02 on skin hydration and transepidermal water loss (TEWL) in subjects with atopic dermatitis after single and multiple applications. Furthermore, data concerning the subjective impression of the study preparation should be collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The principle mode of Ectoin is based on the physical interaction of this compatible solute with water. Ectoin® Dermatitis Cream 7% (EHK02) is able to build an Ectoin® Hydro Complex on the skin providing an effective protection against external stress factors, stabilizing the skin barrier and moisturizing the dry skin. In former studies, it has been shown that it can be used for the symptomatic treatment of atopic dermatitis. This study should confirm the efficacy and safety of EHK02.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Deutschland
      • Wuppertal, Deutschland, Germany, 42287
        • CentroDerm GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with atopic dermatitis without flare up (in eczema free interval).

Description

Inclusion Criteria:

  • Written informed consent form to participate in the study
  • Female or male individual between 18 and 65 years in good general health
  • Diagnosed atopic dermatitis for ≥ 6 months, in asymptomatic stage (asymptomatic stage means without flare up at the beginning of the study)
  • Willingness of the participants to actively participate in the study and to come to the scheduled visits
  • Willingness of the participants to discontinue the application of EHK02 in the test area throughout the course of the study

Exclusion Criteria:

  • Patient has a skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results
  • Patient is self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation
  • Presence of any disease and/or condition and/or history of diseases and/or conditions that according to the investigator may interfere with the conduct of the investigation or the evaluation of the results (such as abnormal laboratory values, chronic inflammatory diseases, immunosuppressive diseases, autoimmune diseases, malignancies, liver or kidney diseases, severe infectious diseases, systemic diseases)
  • Patient has a known allergy against any ingredient of the test products
  • Patient is known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
  • Patient participates in another clinical trial or has participated in another clinical trial within the last 30 days prior to the first day of investigation
  • Patient is involved in the organization of the clinical investigation
  • Subjects receiving the following topical or systemic treatments: Glucocorticoids and / or anti-histamines during the previous week and during the study, Cough suppressants and/or corticoids during the previous 4 weeks,Retinoids and/or immunosuppressants during the previous 6 months
  • Use of skin care products, dermatological therapeutics, shower oils or solarium visits on the test area 7 days prior to the study and during the study
  • Swimming or sauna 24 hours prior to the study and during the study
  • Hair removal on the tested areas within the study period and within 3 days prior to the study
  • Participation in suction blister and UV studies on the tested areas during the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in mean corneometer measurement 8 hours after treatment
Time Frame: baseline (pretreatment), 8 hours after first application (post treatment)
Corneometer is a non-invasive instrument that measures barrier function of the skin surface. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The electrical capacitance of the skin surface will be expressed digitally in arbitrary units. Three measurements will be performed on each test area and the mean will be used to define the skin barrier function of the stratum corneum.
baseline (pretreatment), 8 hours after first application (post treatment)
Change from baseline in mean tewameter measurement 8 hours after treatment
Time Frame: baseline (pretreatment), 8 hours after first application (post treatment)
Transepidermal water loss (TEWL) is affected by environmental factors as humidity, temperature, the time of year (seasonal variation) and the moisture content of the skin (hydration level). Tewameter is a non-invasive instrument that measures skin hydration. Change of skin hydration will be assessed comparing values before (initial condition-pretreatment) and after single application. The TEWL measurement will be measured three times and the mean than will be used to define skin hydration of the stratum corneum. The hydration of the skin surface will be expressed in g/hm².
baseline (pretreatment), 8 hours after first application (post treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in skin hydration over time (1, 8, and 24 hours) after single application compared to initial condition (pretreatment).
Time Frame: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application).
baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Change in skin barrier function over time (1, 8, and 24 h) after single application compared to initial condition (pretreatment).
Time Frame: baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Skin barrier function will be measured with a Corneometer. Physicians will measure values before (pretreatment), and after 1, 8 and 24 hours (post application).
baseline (pretreatment), 1 hour, 8 hours and 24 hours after first application (post treatment).
Change from baseline (initial condition) in mean Tewameter measurement 7 days after treatment.
Time Frame: baseline and 7 days after treatment
Skin hydration will be measured with a Tewameter. Physicians will measure values before (pretreatment), and 7 days after multiple applications.
baseline and 7 days after treatment
Change from baseline (initial condition) in mean Corneometer measurement 7 days after treatment.
Time Frame: baseline and 7 days after treatment
Skin barrier function will be measured with a Corneometer. Physicians will measure values before (pretreatment), and 7 days after multiple applications.
baseline and 7 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitop AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • btph-043-2019_EHK02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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