Back to resultsPharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
CLS001
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
- AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
- Able to participate and willing to give written informed consent and to comply with the study restrictions.
Exclusion Criteria:
- Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
- Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
Sites / Locations
- Centre for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CLS001 topical gel, 2.5%
CLS001 topical gel 1%
Vehicle gel
Arm Description
Outcomes
Primary Outcome Measures
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)
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
Clinical assessment (Change in patient symptoms over time using pruritis VAS)
Change in patient symptoms over time using pruritis VAS
Clinical Assessment (Change in lesion size over time)
Change in lesion size over time
Clinical assessment (Change in patient SCORAD scale score over time)
Change in patient SCORAD scale score over time
Secondary Outcome Measures
Safety Assessment (Adverse events)
Adverse events will be collected throughout the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02456480
Brief Title
Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLS001 topical gel, 2.5%
Arm Type
Experimental
Arm Title
CLS001 topical gel 1%
Arm Type
Experimental
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CLS001
Intervention Description
topical gel
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
topical gel
Primary Outcome Measure Information:
Title
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)
Description
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
Title
Clinical assessment (Change in patient symptoms over time using pruritis VAS)
Description
Change in patient symptoms over time using pruritis VAS
Time Frame
42 Days
Title
Clinical Assessment (Change in lesion size over time)
Description
Change in lesion size over time
Time Frame
42 Days
Title
Clinical assessment (Change in patient SCORAD scale score over time)
Description
Change in patient SCORAD scale score over time
Time Frame
42 Days
Secondary Outcome Measure Information:
Title
Safety Assessment (Adverse events)
Description
Adverse events will be collected throughout the study
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
Able to participate and willing to give written informed consent and to comply with the study restrictions.
Exclusion Criteria:
Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. (Koos) Burggraaf, MD, PhD
Organizational Affiliation
Centre for Human Drug Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Human Drug Research
City
Zernikedreef 8
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
32315497
Citation
Niemeyer-van der Kolk T, van der Wall H, Hogendoorn GK, Rijneveld R, Luijten S, van Alewijk DCJG, van den Munckhof EHA, de Kam ML, Feiss GL, Prens EP, Burggraaf J, Rissmann R, van Doorn MBA. Pharmacodynamic Effects of Topical Omiganan in Patients With Mild to Moderate Atopic Dermatitis in a Randomized, Placebo-Controlled, Phase II Trial. Clin Transl Sci. 2020 Sep;13(5):994-1003. doi: 10.1111/cts.12792. Epub 2020 May 1.
Results Reference
derived
Learn more about this trial
Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis
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