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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Atopic Dermatitis
• Intervention / Treatment: Device: Atopiclair; Device: EHK02-01

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13507
    • Hautarztzentrum Tegel
  • Freiburg, Germany, 79100
    • Hautarztpraxis
  • Mahlow, Germany, 15831
    • Gemeinschaftspraxis Mahlow
  • Potsdam, Germany, 14469
    • Haut- und Lasercentrum Potsdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Atopiclair	Device: Atopiclair; topical applied cream, twice daily; Other Names: MAS063DP; Zarzenda; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of a modified, objective (local) SCORAD	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of local IGA	28 days
Change of Pruritus	28 days
Patient's judgment on efficacy	28 days
AEs during treatment phase	28 days
Physical examination	28 days
Patient's assessment of tolerability and safe	28 days
change of the modified, objective local SCORAD	7 days

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (ESTIMATE): March 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2011
• Last Update Submitted That Met QC Criteria: October 17, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Treatment; Atopic dermatitis; Medical device; Ectoine; Atopiclair
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Inflammatory Agents; Glycyrrhetinic Acid
• Other Study ID Numbers: 133-002; 0010287 (REGISTRY: DIMDI)