Status:
COMPLETED
Effect of Ectoin Dermatitis Cream 7% on Skin Hydration and Skin Barrier Function
Lead Sponsor:
Bitop AG
Conditions:
Atopic Dermatitis Eczema
Eligibility:
All Genders
18-65 years
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 at...
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 provid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04097327
Start Date
August 23 2019
End Date
December 31 2019
Last Update
January 10 2020
Active Locations (1)
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1
Centroderm GmbH
Wuppertal, Deutschland, Germany, 42287