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Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091426
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Omiganan Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacodynamics, Safety, Tolerability and Efficacy of Omiganan BID in Patients With Mild to Moderate Atopic Dermatitis
Actual Study Start Date : March 8, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Omiganan 1% Drug: Omiganan
Omiganan 1%

Experimental: Omiganan 1.75% Drug: Omiganan
Omiganan 1.75%

Experimental: Omiganan 2.5% Drug: Omiganan
Omiganan 2.5%

Placebo Comparator: Vehicle Drug: Placebo
Vehicle




Primary Outcome Measures :
  1. Clinical Evaluation (oSCORAD) [ Time Frame: Within 7 Weeks ]
    oSCORAD Assessment

  2. Clinical Evaluation (EASI) [ Time Frame: Within 7 Weeks ]
    EASI Assessment

  3. Clinical Evaluation (IGA) [ Time Frame: Within 7 Weeks ]
    IGA Assessment

  4. Patient-Orientated Outcome Measure (POEM) [ Time Frame: Within 7 Weeks ]
    Patient Assessment by collecting POEM

  5. Dermatology Life Quality Index (DLQI) [ Time Frame: Within 7 Weeks ]
    Assessment of health-related quality of life by measuring DLQI

  6. eDiary [ Time Frame: Within 4 Weeks ]
    Singe-Question assessment of pruritus and sleeplessness

  7. Clinical Photography [ Time Frame: Within 7 Weeks ]
    Whole body photograph for qualitative and observational record

  8. Pharmacodynamics (Biomarkers) [ Time Frame: Within 7 Weeks ]
    Local biomarkers sequencing

  9. Pharmacodynamics (Microbiome) [ Time Frame: Within 7 Weeks ]
    Microbiome analysis

  10. Pharmacodynamics (Microbiology) [ Time Frame: Within 7 Weeks ]
    Microbiology analysis

  11. Pharmacodynamics (TEWL) [ Time Frame: Within 7 Weeks ]
    Transepidermal water-loss assessment

  12. Pharmacodynamics (Thermography) [ Time Frame: Within 7 Weeks ]
    Skin temperature measurements will be taken

  13. Pharmacodynamics (TAP) [ Time Frame: Within 7 Weeks ]
    Analysis of biomarkers captured by Transdermal Analysis Patch

  14. Pharmacodynamics (Cytokines) [ Time Frame: Within 7 Weeks ]
    Cytokine assessment via blood evaluation


Secondary Outcome Measures :
  1. Safety (AE) [ Time Frame: Within 7 Weeks ]
    Adverse Events will be collected throughout the study

  2. Safety (Vital Signs) [ Time Frame: Within 7 Weeks ]
    Vital Signs will be collected throughout the study

  3. Safety (Clinical Laboratory Tests) [ Time Frame: Within 7 Weeks ]
    Lab samples collected in various timepoints within the study

  4. Safety (ECG) [ Time Frame: Within 7 Weeks ]
    ECGs collected before beginning and end of study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
  • Confirmed AD diagnosis;
  • Symptoms present for at least 1 year;
  • EASI between 7.1 - 50.0, inclusive at screening;
  • 2-20% body surface area (BSA) affected at screening;
  • Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
  • Able to participate and willing to give written informed consent and to comply with the study restrictions;
  • Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria:

  • Any current and / or recurrent clinical significant skin condition other than AD;
  • Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
  • Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);
  • Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
  • Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
  • Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
  • Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
  • Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091426


Locations
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Netherlands
LUMC/Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Maruho Co., Ltd.
Investigators
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Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT03091426    
Other Study ID Numbers: CLS001-CO-PR-014
2016-003849-28 ( EudraCT Number )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antimicrobial Cationic Peptides
Anti-Infective Agents