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

Bitop

Status

Completed

Conditions

Mild to Moderate Atopic Dermatitis

Treatments

Device: EHK02-01

Device: Atopiclair

Study type

Interventional

Funder types

Industry

Identifiers

NCT01079897

0010287 (Registry Identifier)

133-002

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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