COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079897
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : October 18, 2011
Information provided by (Responsible Party):
Bitop AG

Brief Summary:
This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days. Response to therapy is recorded at each visit.

Condition or disease Intervention/treatment Phase
Mild to Moderate Atopic Dermatitis Device: Atopiclair Device: EHK02-01 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Comparator-controlled, Double-blind, Multicenter Intra-individual Clinical Trial to Evaluate the Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis
Study Start Date : March 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Atopiclair Device: Atopiclair
topical applied cream, twice daily
Other Names:
  • Zarzenda
  • MAS063DP
  • Atopiclair non-steroidal cream

Experimental: EHK02-01
Ectoine containing cream
Device: EHK02-01
topical applied cream containing 7% ectoine
Other Names:
  • ectoine-containing cream,
  • 7% Ectoin

Primary Outcome Measures :
  1. change of a modified, objective (local) SCORAD [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Change of local IGA [ Time Frame: 28 days ]
  2. Change of Pruritus [ Time Frame: 28 days ]
  3. Patient's judgment on efficacy [ Time Frame: 28 days ]
  4. AEs during treatment phase [ Time Frame: 28 days ]
  5. Physical examination [ Time Frame: 28 days ]
  6. Patient's assessment of tolerability and safe [ Time Frame: 28 days ]
  7. change of the modified, objective local SCORAD [ Time Frame: 7 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female or male individuals between 18 and 65 years in good general health diagnosed atopic dermatitis for ≥ 6 months, in active stage (active stage means severity as measured by overall IGA-Score between 1 and 4)
  • At least two comparable areas of stable atopic eczema on bilateral symmetric corresponding sides of the extremities or the body (except for head and genital area), each of at least 10 cm², with a modified, objective local SCORAD of the test areas > 5
  • Both lesional areas of interest must have a difference in the modified, objective local SCORAD of ≤ 3
  • Willingness to adhere to the schedule of the investigation, concomitant therapy prohibitions, restrictions, treatment regimen and procedures described in the CIP
  • Written informed consent to participate in the trial, prior to any investigation related procedures, indicating an understanding of the purpose of the clinical investigation
  • A patient of childbearing potential agrees to use a contraceptive methods for the duration of the investigation according to CPMP/ICH 286/95 note 3

Exclusion Criteria:

  • Patients who are self-reported to be pregnant, nursing or planning pregnancy during the clinical investigation
  • Patients with any skin disease that in the investigator's opinion may interfere with the conduct of the study or the evaluation of the results (e.g. psoriasis)
  • Patients with a known malignancy
  • 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 dis-eases, immunosuppressive diseases, autoimmune diseases, liver or kidney diseases, severe infectious diseases)
  • Patients who did not respect the wash-out periods prior to and during the clinical investigation
  • Vaccination within 6 days prior to enrolment and during the study.
  • Patients with a known allergy against any ingredient of the test products
  • Patients who are known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
  • Patients who participate in another clinical trial or have participated in another clinical trial within the last 30 days prior to the first day of investigation
  • Patients who are involved in the organization of the clinical investigation
  • Patients that are in any way dependant on the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079897

Layout table for location information
Hautarztzentrum Tegel
Berlin, Germany, 13507
Freiburg, Germany, 79100
Gemeinschaftspraxis Mahlow
Mahlow, Germany, 15831
Haut- und Lasercentrum Potsdam
Potsdam, Germany, 14469
Sponsors and Collaborators
Bitop AG
Layout table for investigator information
Principal Investigator: Wolfgang Vanscheidt, Professor Professor Dr. med Wolfgang Vanscheid (Hautarzt, Allergologie, Phlebologie)
Principal Investigator: Tanja Fischer, Dr. Haut- und Lasercentrum Potsdam
Principal Investigator: Martin Miehe, Dr. Hautarztzentrum Tegel
Principal Investigator: Michael Sebastian, Dr. Facharzt für Dermatologie
Layout table for additonal information
Responsible Party: Bitop AG Identifier: NCT01079897    
Other Study ID Numbers: 133-002
0010287 ( Registry Identifier: DIMDI )
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011
Keywords provided by Bitop AG:
Atopic dermatitis
Medical device
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Glycyrrhetinic Acid
Anti-Inflammatory Agents