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Trial record 2 of 25 for:    Ectoine

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.
 
ClinicalTrials.gov Identifier: NCT01079897
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
Bitop AG

Tracking Information
First Submitted Date  ICMJE March 2, 2010
First Posted Date  ICMJE March 3, 2010
Last Update Posted Date October 18, 2011
Study Start Date  ICMJE March 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
change of a modified, objective (local) SCORAD [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01079897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
  • Change of local IGA [ Time Frame: 28 days ]
  • Change of Pruritus [ Time Frame: 28 days ]
  • Patient's judgment on efficacy [ Time Frame: 28 days ]
  • AEs during treatment phase [ Time Frame: 28 days ]
  • Physical examination [ Time Frame: 28 days ]
  • Patient's assessment of tolerability and safe [ Time Frame: 28 days ]
  • change of the modified, objective local SCORAD [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mild to Moderate Atopic Dermatitis
Intervention  ICMJE
  • Device: Atopiclair
    topical applied cream, twice daily
    Other Names:
    • Zarzenda
    • MAS063DP
    • Atopiclair non-steroidal cream
  • Device: EHK02-01
    topical applied cream containing 7% ectoine
    Other Names:
    • ectoine-containing cream,
    • 7% Ectoin
Study Arms  ICMJE
  • Active Comparator: Atopiclair
    Intervention: Device: Atopiclair
  • Experimental: EHK02-01
    Ectoine containing cream
    Intervention: Device: EHK02-01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2010)
64
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2010)
60
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01079897
Other Study ID Numbers  ICMJE 133-002
0010287 ( Registry Identifier: DIMDI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bitop AG
Study Sponsor  ICMJE Bitop AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Bitop AG
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP