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

NCT ID: NCT04097327

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2019-12-31

Brief Summary

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.

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.

Conditions

Atopic Dermatitis Eczema

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Ectoin Dermatitis Cream 7% (EHK02)

Application of Ectoin Dermatitis Cream in accordance with the instructions for use

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bitop AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centroderm GmbH

Wuppertal, Deutschland, Germany

Countries

Germany

Other Identifiers

btph-043-2019_EHK02

Identifier Type: -

Identifier Source: org_study_id