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

Mild to Moderate Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079897
• Other study ID #: 133-002
• Secondary ID: 0010287
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: October 17, 2011
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2011
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Mild to Moderate Atopic Dermatitis

Intervention

Device:
• Atopiclair
topical applied cream, twice daily
• EHK02-01
topical applied cream containing 7% ectoine

Locations

Country	Name	City	State
Germany	Hautarztzentrum Tegel	Berlin
Germany	Hautarztpraxis	Freiburg
Germany	Gemeinschaftspraxis Mahlow	Mahlow
Germany	Haut- und Lasercentrum Potsdam	Potsdam

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of a modified, objective (local) SCORAD		28 days	No
Secondary	Change of local IGA		28 days	No
Secondary	Change of Pruritus		28 days	No
Secondary	Patient's judgment on efficacy		28 days	No
Secondary	AEs during treatment phase		28 days	Yes
Secondary	Physical examination		28 days	Yes
Secondary	Patient's assessment of tolerability and safe		28 days	Yes
Secondary	change of the modified, objective local SCORAD		7 days	No