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

Sponsor:	Bitop AG
Information provided by:	Bitop AG
ClinicalTrials.gov Identifier:	NCT01079897

Purpose

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	Intervention
Mild to Moderate Atopic Dermatitis	Device: Atopiclair Device: EHK02-01

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Bitop AG:

Primary Outcome Measures:

change of a modified, objective (local) SCORAD [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of local IGA [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Change of Pruritus [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Patient's judgment on efficacy [ Time Frame: 28 days ] [ Designated as safety issue: No ]
AEs during treatment phase [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Patient's assessment of tolerability and safe [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
change of the modified, objective local SCORAD [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Atopiclair: Active Comparator	Device: Atopiclair topical applied cream, twice daily
EHK02-01: Experimental Ectoine containing cream	Device: EHK02-01 topical applied cream containing 7% ectoine

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079897

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	bitop AG ( Dr. Kerstin Reinelt )
ClinicalTrials.gov Identifier:	NCT01079897 History of Changes
Other Study ID Numbers:	133-002, 0010287
Study First Received:	March 2, 2010
Last Updated:	August 11, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bitop AG:

Atopic dermatitis
Ectoine
Treatment
Atopiclair
Medical device

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn

Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 01, 2010