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Trial record 29 of 154 for:    Dermatitis, Atopic, 8

Pharmacodynamics of Omiganan (CLS001) 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: NCT02456480
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: CLS001 Drug: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 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 in Patients With Mild to Moderate Atopic Dermatitis
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: CLS001 topical gel, 2.5% Drug: CLS001
topical gel

Experimental: CLS001 topical gel 1% Drug: CLS001
topical gel

Placebo Comparator: Vehicle gel Drug: Vehicle
topical gel




Primary Outcome Measures :
  1. Pharmacodynamic (Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion) [ Time Frame: 42 Days ]
    Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion

  2. Clinical assessment (Change in patient symptoms over time using pruritis VAS) [ Time Frame: 42 Days ]
    Change in patient symptoms over time using pruritis VAS

  3. Clinical Assessment (Change in lesion size over time) [ Time Frame: 42 Days ]
    Change in lesion size over time

  4. Clinical assessment (Change in patient SCORAD scale score over time) [ Time Frame: 42 Days ]
    Change in patient SCORAD scale score over time


Secondary Outcome Measures :
  1. Safety Assessment (Adverse events) [ Time Frame: 42 days ]
    Adverse events will be collected throughout the study



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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:

  1. Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
  2. AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
  3. Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

  1. Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
  2. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
  3. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.

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): NCT02456480


Locations
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Netherlands
Centre for Human Drug Research
Zernikedreef 8, 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: NCT02456480     History of Changes
Other Study ID Numbers: CLS001-CO-PR-008
2014-003689-26 ( EudraCT Number )
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
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