Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

A Phase 2 study testing Omiganan in people with Atopic Dermatitis, run by Maruho Co., Ltd. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: Omiganan
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteNetherlands
Study dates: 8 Mar 2017to 20 Dec 2017
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

LUMC/Centre for Human Drug Research
Leiden

Other trials in Netherlands

About this study

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

Conditions: Atopic Dermatitis
Being tested: Omiganan, Placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmigananDrug
Omiganan 1%
OmigananDrug
Omiganan 1.75%
OmigananDrug
Omiganan 2.5%
PlaceboDrug
Vehicle

Study groups in NCT03091426
Study group	Role	What they receive
Omiganan 1%	Experimental	Not described Receives: Drug: Omiganan
Omiganan 1.75%	Experimental	Not described Receives: Drug: Omiganan
Omiganan 2.5%	Experimental	Not described Receives: Drug: Omiganan
Vehicle	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Evaluation (oSCORAD)
oSCORAD Assessment
Measured: Within 7 Weeks
Clinical Evaluation (EASI)
EASI Assessment
Measured: Within 7 Weeks
Clinical Evaluation (IGA)
IGA Assessment
Measured: Within 7 Weeks
Patient-Orientated Outcome Measure (POEM)
Patient Assessment by collecting POEM
Measured: Within 7 Weeks
Dermatology Life Quality Index (DLQI)
Assessment of health-related quality of life by measuring DLQI
Measured: Within 7 Weeks
eDiary
Singe-Question assessment of pruritus and sleeplessness
Measured: Within 4 Weeks
Clinical Photography
Whole body photograph for qualitative and observational record
Measured: Within 7 Weeks
Pharmacodynamics (Biomarkers)
Local biomarkers sequencing
Measured: Within 7 Weeks
Pharmacodynamics (Microbiome)
Microbiome analysis
Measured: Within 7 Weeks
Pharmacodynamics (Microbiology)
Microbiology analysis
Measured: Within 7 Weeks
Pharmacodynamics (TEWL)
Transepidermal water-loss assessment
Measured: Within 7 Weeks
Pharmacodynamics (Thermography)
Skin temperature measurements will be taken
Measured: Within 7 Weeks
Pharmacodynamics (TAP)
Analysis of biomarkers captured by Transdermal Analysis Patch
Measured: Within 7 Weeks
Pharmacodynamics (Cytokines)
Cytokine assessment via blood evaluation
Measured: Within 7 Weeks

Secondary outcomes (4)

Safety (AE)
Adverse Events will be collected throughout the study
Measured: Within 7 Weeks
Safety (Vital Signs)
Vital Signs will be collected throughout the study
Measured: Within 7 Weeks
Safety (Clinical Laboratory Tests)
Lab samples collected in various timepoints within the study
Measured: Within 7 Weeks
Safety (ECG)
ECGs collected before beginning and end of study
Measured: Within 7 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 201720 Dec 2017

First posted27 Mar 2017
Study start8 Mar 2017
Primary completion20 Dec 2017
Study completion20 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03091426
Sponsor's protocol ID: CLS001-CO-PR-014
Other IDs: 2016-003849-28, 2016
Status last verified: Dec 2017
First submitted: 21 Mar 2017
Last updated: 27 Dec 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03091426
Acronym / sponsor ID: CLS001-CO-PR-014
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Maruho Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Mar 2017 (actual)
Primary completion: 20 Dec 2017 (actual)
Study completion: 20 Dec 2017 (actual)
First posted: 27 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Omiganan 1%	Experimental	Drug: Omiganan
Omiganan 1.75%	Experimental	Drug: Omiganan
Omiganan 2.5%	Experimental	Drug: Omiganan
Vehicle	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OmigananOmiganan 1%	Drug	Omiganan 1%
OmigananOmiganan 1.75%	Drug	Omiganan 1.75%
OmigananOmiganan 2.5%	Drug	Omiganan 2.5%
PlaceboVehicle	Drug	Vehicle

Primary outcome

Clinical Evaluation (oSCORAD)
Time frame: Within 7 Weeks
oSCORAD Assessment
Clinical Evaluation (EASI)
Time frame: Within 7 Weeks
EASI Assessment
Clinical Evaluation (IGA)
Time frame: Within 7 Weeks
IGA Assessment
Patient-Orientated Outcome Measure (POEM)
Time frame: Within 7 Weeks
Patient Assessment by collecting POEM
Dermatology Life Quality Index (DLQI)
Time frame: Within 7 Weeks
Assessment of health-related quality of life by measuring DLQI
eDiary
Time frame: Within 4 Weeks
Singe-Question assessment of pruritus and sleeplessness
Clinical Photography
Time frame: Within 7 Weeks
Whole body photograph for qualitative and observational record
Pharmacodynamics (Biomarkers)
Time frame: Within 7 Weeks
Local biomarkers sequencing
Pharmacodynamics (Microbiome)
Time frame: Within 7 Weeks
Microbiome analysis
Pharmacodynamics (Microbiology)
Time frame: Within 7 Weeks
Microbiology analysis
Pharmacodynamics (TEWL)
Time frame: Within 7 Weeks
Transepidermal water-loss assessment
Pharmacodynamics (Thermography)
Time frame: Within 7 Weeks
Skin temperature measurements will be taken
Pharmacodynamics (TAP)
Time frame: Within 7 Weeks
Analysis of biomarkers captured by Transdermal Analysis Patch
Pharmacodynamics (Cytokines)
Time frame: Within 7 Weeks
Cytokine assessment via blood evaluation

4 secondary outcomes

Safety (AE)
Time frame: Within 7 Weeks
Safety (Vital Signs)
Time frame: Within 7 Weeks
Safety (Clinical Laboratory Tests)
Time frame: Within 7 Weeks
Safety (ECG)
Time frame: Within 7 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.

Related trials for Atopic Dermatitis

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

J. (Koos) Burggraaf, MD, PhD principal investigator

Centre for Human Drug Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omiganan in people with Atopic Dermatitis, run by Maruho Co., Ltd. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Evaluation (oSCORAD) (time frame: Within 7 Weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03091426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.