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

NCT01079897 | Completed

• 2 other identifiers: 133-0020010287
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

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.

Conditions

Mild to Moderate Atopic Dermatitis

Keywords

Atopic dermatitis; Ectoine; Treatment; Atopiclair; Medical device

Outcome Measures

Primary Outcomes (1)

• change of a modified, objective (local) SCORAD

  28 days

Secondary Outcomes (7)

• 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

Study Arms (2)

Atopiclair

ACTIVE COMPARATOR

Device: Atopiclair

EHK02-01

EXPERIMENTAL

Ectoine containing cream

Device: EHK02-01

Interventions

Atopiclair DEVICE

topical applied cream, twice daily

Also known as: Zarzenda, MAS063DP, Atopiclair non-steroidal cream

Atopiclair

EHK02-01 DEVICE

topical applied cream containing 7% ectoine

Also known as: ectoine-containing cream,, 7% Ectoin

EHK02-01

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (4)

Hautarztzentrum Tegel

Berlin, 13507, Germany

Location

Hautarztpraxis

Freiburg im Breisgau, 79100, Germany

Location

Gemeinschaftspraxis Mahlow

Mahlow, 15831, Germany

Location

Haut- und Lasercentrum Potsdam

Potsdam, 14469, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 18, 2011

Record last verified: 2011-10

Locations

DE (4)