RosaceaPhase 3NCT02576860

Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

A Phase 3 study testing CLS001 (Omiganan) in people with Rosacea, run by Maruho Co., Ltd. at 47 sites in 9 countries.

Completed

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

Trial summary

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Rosacea
What is being tested?: CLS001 (Omiganan)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 263 participants
Where: 47 sitesin 9 countries
Study dates: Oct 2015to 5 Sep 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy, male and non-pregnant female subjects, 18 years of age or older.
A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
Subjects with the presence of telangiectasia at Baseline.
Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Who cannot join

Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
Subjects with nodular rosacea.
Standard exclusion criteria.

Trial locations and contacts

47 sites in 9 countries.

Country

City, postcode or hospital

47 sites in 9 countries

United States20 sites

Study site
Arlington, Texas
Study site
Boynton Beach, Florida
Study site
Charleston, South Carolina
Study site
Fort Smith, Arkansas
Study site
Fort Washington, Pennsylvania
Study site
High Point, North Carolina
Study site
Manhattan Beach, California
Study site
Miami, Florida
Study site
New York, New York
Study site
Oceanside, California
Study site
Omaha, Nebraska
Study site
Plainfield, Indiana
Study site
Raleigh, North Carolina
Study site
Rogers, Arkansas
Study site
San Antonio, Texas
Study site
Stony Brook, New York
Study site
Verona, New Jersey
Study site
Washington D.C., District of Columbia
Study site
Watertown, Massachusetts
Study site
Winston-Salem, North Carolina

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Germany10 sites

Study site
Berlin
Study site
Bochum
Study site
Bonn
Study site
Cologne
Study site
Friedrichshafen
Study site
Hamburg
Study site
Lingen
Study site
Mönchengladbach
Study site
Osnabrück
Study site
Schweinfurt

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Australia4 sites

Study site
Box Hill, Victoria
Study site
Kogarah, New South Wales
Study site
Liverpool, New South Wales
Study site
Phillip, Australian Capital Territory

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Canada4 sites

Study site
Courtice, Ontario
Study site
Peterborough, Ontario
Study site
Surrey, British Columbia
Study site
Windsor, Ontario

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France3 sites

Study site
Grenoble
Study site
Nantes
Study site
Quimper

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United Kingdom3 sites

Study site
Birmingham
Study site
Bradford, England
Study site
London

Other trials in United Kingdom

Netherlands1 site

Study site
Nijmegen

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New Zealand1 site

Study site
Auckland

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Sweden1 site

Study site
Halmstad

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About this study

Official title: A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Conditions: Rosacea
Being tested: CLS001 (Omiganan), Vehicle
Medical subject headings: Rosacea

What participants receive

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

CLS001 (Omiganan)Drug
Topical gel
VehicleDrug
Vehicle gel

Study groups in NCT02576860
Study group	Role	What they receive
Treatment	Experimental	CLS001 (Omignan) gel applied once daily Receives: Drug: CLS001 (Omiganan)
Vehicle Gel	Placebo comparator	Vehicle gel applied once daily Receives: Drug: Vehicle

What is being measured

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

Efficacy Absolute Change in Inflammatory Lesion Count
Absolute change in inflammatory lesion count from baseline to Week 12.
Measured: 12 weeks
Efficacy IGA: 2 Grade Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Measured: 12 weeks

Secondary outcomes (4)

Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 9.
Measured: 9 weeks
Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 6.
Measured: 6 weeks
Efficacy IGA: 2 Point Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Measured: 9 Weeks
Efficacy IGA: 2 Point Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Measured: 6 Weeks

Timeline

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

Oct 20155 Sep 2017

First posted15 Oct 2015 (estimated)
Study startOct 2015
Primary completion27 Feb 2017
Study completion5 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RosaceaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02576860
Sponsor's protocol ID: CLS001-CO-PR-005
Status last verified: Jul 2022
First submitted: 13 Oct 2015
Last updated: 2 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
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RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period
ClinicalTrials.gov ID: NCT02576860
Acronym / sponsor ID: CLS001-CO-PR-005
Conditions: Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: Maruho Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: 27 Feb 2017 (actual)
Study completion: 5 Sep 2017 (actual)
First posted: 15 Oct 2015 (estimated)
Results: Posted 8 Jul 2022

Clinical summary

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

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Drug: CLS001 (Omiganan)CLS001 (Omignan) gel applied once daily
Vehicle Gel	Placebo comparator	Drug: VehicleVehicle gel applied once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy, male and non-pregnant female subjects, 18 years of age or older.
A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
Subjects with the presence of telangiectasia at Baseline.
Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Key exclusion criteria (3 listed)

Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
Subjects with nodular rosacea.
Standard exclusion criteria.

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
CLS001 (Omiganan)Topical gel	Drug	Treatment
VehicleVehicle gel	Drug	Vehicle Gel

Primary outcome

Efficacy Absolute Change in Inflammatory Lesion Count
Time frame: 12 weeks
Absolute change in inflammatory lesion count from baseline to Week 12.
Efficacy IGA: 2 Grade Reduction
Time frame: 12 weeks
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).

4 secondary outcomes

Efficacy The Absolute Change in Inflammatory Lesions
Time frame: 9 weeks
Efficacy The Absolute Change in Inflammatory Lesions
Time frame: 6 weeks
Efficacy IGA: 2 Point Reduction
Time frame: 9 Weeks
Efficacy IGA: 2 Point Reduction
Time frame: 6 Weeks

Results and safety

Results posted to the registry on 8 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	136	111
Vehicle Gel	127	103

Primary outcome: Efficacy Absolute Change in Inflammatory Lesion Count

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: Lesions

Measure	Treatment n = 136	Vehicle Gel n = 127
Value	-19.8 (2.29)	-20.9 (2.36)

Treatment vs Vehicle Gel: p = 0.799, ANCOVA

Population analysed: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

Primary outcome: Efficacy IGA: 2 Grade Reduction

Time frame: 12 weeks. Number. Unit: Percentage of Subjects

Measure	Treatment n = 136	Vehicle Gel n = 127
Value	24.6	25.6

Treatment vs Vehicle Gel: p = 0.858, Cochran-Mantel-Haenszel

Population analysed: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 115 Days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	1 of 136 (0.7%)	47 of 136 (34.6%)	0 of 136
Vehicle Gel	0 of 127 (0%)	36 of 127 (28.3%)	0 of 127

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rosacea

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

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.

The record lists no contact. Use the official record to reach the sponsor.

47 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CLS001 (Omiganan) in people with Rosacea, run by Maruho Co., Ltd. at 47 sites in 9 countries.

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 5 inclusion and 3 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Germany, Australia, Canada, France and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy Absolute Change in Inflammatory Lesion Count (time frame: 12 weeks). The study lists 2 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 NCT02576860.

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 2 Aug 2022.