NCT02456480

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

May 1, 2015

Last Update Submit

July 25, 2016

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

  • 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

    42 Days

  • Clinical assessment (Change in patient symptoms over time using pruritis VAS)

    Change in patient symptoms over time using pruritis VAS

    42 Days

  • Clinical Assessment (Change in lesion size over time)

    Change in lesion size over time

    42 Days

  • Clinical assessment (Change in patient SCORAD scale score over time)

    Change in patient SCORAD scale score over time

    42 Days

Secondary Outcomes (1)

  • Safety Assessment (Adverse events)

    42 days

Study Arms (3)

CLS001 topical gel, 2.5%

EXPERIMENTAL
Drug: CLS001

CLS001 topical gel 1%

EXPERIMENTAL
Drug: CLS001

Vehicle gel

PLACEBO COMPARATOR
Drug: Vehicle

Interventions

CLS001DRUG

topical gel

CLS001 topical gel 1%CLS001 topical gel, 2.5%
VehicleDRUG

topical gel

Vehicle gel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human Drug Research

Zernikedreef 8, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 32315497DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • J. (Koos) Burggraaf, MD, PhD

    Centre for Human Drug Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

May 1, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

NL(1)