CClinicalTrials.gg
Sign In
CompletedNCT02456480Updated Jul 28, 2016

Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

A Phase 2 interventional study of CLS001 and Vehicle in Atopic Dermatitis, sponsored by Maruho Co., Ltd.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-28.

Sponsored by Maruho Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 37 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Maruho Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    CLS001 topical gel, 2.5%

    Drug: CLS001

  • Experimental
    CLS001 topical gel 1%

    Drug: CLS001

  • Placebo comparator
    Vehicle gel

    Drug: Vehicle

Interventions

  • DrugCLS001

    topical gel

  • DrugVehicle

    topical gel

06

What researchers measure

Primary outcomes

  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)

    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

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

    Change in patient symptoms over time using pruritis VAS

    Time frame: 42 Days

  3. Clinical Assessment (Change in lesion size over time)

    Change in lesion size over time

    Time frame: 42 Days

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

    Change in patient SCORAD scale score over time

    Time frame: 42 Days

Secondary outcomes

  1. Safety Assessment (Adverse events)

    Adverse events will be collected throughout the study

    Time frame: 42 days

07

Study locations

1 site
  • Centre for Human Drug Research
    Zernikedreef 8, Netherlands
08

References and documents

Publications

  • 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. PubMed 32315497 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02456480
Lead sponsor
Maruho Co., Ltd.
Responsible party
Sponsor
First posted
May 28, 2015
Start date
May 2015
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Jul 28, 2016

Study contacts

J. (Koos) Burggraaf, MD, PhD
principal investigator · Centre for Human Drug Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dermatitis, Atopic→

Other studies from this sponsor

Maruho Co., Ltd.

Start the discussion