RosaceaPhase 3NCT02547441

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 41 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: 463 participants
Where: 41 sitesin 9 countries
Study dates: Dec 2015to 13 Apr 2018
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

41 sites in 9 countries.

Country

City, postcode or hospital

41 sites in 9 countries

United States13 sites

Study site
Albuquerque, New Mexico
Study site
Arlington Heights, Illinois
Study site
Carmel, Indiana
Study site
Charlottesville, Virginia
Study site
Dallas, Texas
Study site
Fort Gratiot, Michigan
Study site
Fremont, California
Study site
Miami, Florida
Study site
Miramar, Florida
Study site
New York, New York
Study site
San Antonio, Texas
Study site
Stony Brook, New York
Study site
Tampa, Florida

Other trials in United States

Germany11 sites

Study site
Augsburg
Study site
Berlin
Study site
Bochum
Study site
Darmstadt
Study site
Dresden
Study site
Dülmen
Study site
Frankfurt
Study site
Ibbenbueren
Study site
Lübeck
Study site
Mahlow
Study site
Münster

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France5 sites

Study site
Brest
Study site
Nancy
Study site
Nice
Study site
Rouen
Study site
Thionville

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United Kingdom4 sites

Study site
Lanarkshire
Study site
Leeds
Study site
Manchester
Study site
Surrey

Other trials in United Kingdom

Australia3 sites

Study site
Carlton, Victoria
Study site
East Melbourne, Victoria
Study site
Woolloongabba, Queensland

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Canada2 sites

Study site
Hamilton, Ontario
Study site
Toronto, Ontario

Other trials in Canada

Netherlands1 site

Study site
Rotterdam

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New Zealand1 site

Study site
Hamilton

Other trials in New Zealand

Sweden1 site

Study site
Gothenburg

Other trials in Sweden

About this study

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

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 NCT02547441
Study group	Role	What they receive
Treatment	Experimental	CLS001 (Omiganan) 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.

Change in Inflammatory Lesion Count From Baseline to Week 12
Change from Baseline to Week 12 in Inflammatory Lesion Count
Measured: 12 weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction.
Percentage of participants 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)

Change in the Number of Inflammatory Lesions From Baseline at Week 9
The absolute change in inflammatory lesions from baseline to Week 9
Measured: 9 weeks
Change in the Number of Inflammatory Lesions From Baseline at Week 6
The absolute change in inflammatory lesions from baseline to Week 6
Measured: 6 weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
Percentage of participants 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
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
Percentage of participants 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.

Dec 201513 Apr 2018

First posted11 Sep 2015 (estimated)
Study startDec 2015
Primary completion5 Jul 2017
Study completion13 Apr 2018

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: 463 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547441
Sponsor's protocol ID: CLS001-CO-PR-004
Status last verified: Jul 2022
First submitted: 9 Sep 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
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

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 a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension
ClinicalTrials.gov ID: NCT02547441
Acronym / sponsor ID: CLS001-CO-PR-004
Conditions: Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 463 participants (actual)
Lead sponsor: Maruho Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2015 (actual)
Primary completion: 5 Jul 2017 (actual)
Study completion: 13 Apr 2018 (actual)
First posted: 11 Sep 2015 (estimated)
Results: Posted 2 Aug 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 (Omiganan) 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

Change in Inflammatory Lesion Count From Baseline to Week 12
Time frame: 12 weeks
Change from Baseline to Week 12 in Inflammatory Lesion Count
Percentage of Participants Who Achieved 2 Grade IGA Reduction.
Time frame: 12 weeks
Percentage of participants 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

Change in the Number of Inflammatory Lesions From Baseline at Week 9
Time frame: 9 weeks
Change in the Number of Inflammatory Lesions From Baseline at Week 6
Time frame: 6 weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
Time frame: 9 Weeks
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
Time frame: 6 Weeks

Results and safety

Results posted to the registry on 2 Aug 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
CLS001 (Omiganan) Gel	235	211
Vehicle Gel	228	196

Primary outcome: Change in Inflammatory Lesion Count From Baseline to Week 12

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

Measure	Treatment n = 235	Vehicle Gel n = 228
Value	-18.1 (1.77)	-13.5 (1.85)

Treatment vs Vehicle Gel: p = 0.043, ANCOVA

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

Primary outcome: Percentage of Participants Who Achieved 2 Grade IGA Reduction.

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

Measure	Treatment n = 235	Vehicle Gel n = 228
Value	26.3	16.9

Treatment vs Vehicle Gel: p = 0.019, 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: 12-week in Double-Blind Period and maximum 1 year in Open-Label Period. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CLS001 (Omiganan) Gel (Double-Blind Period)	4 of 235 (1.7%)	83 of 235 (35.3%)	0 of 235
Vehicle Gel (Double-Blind Period)	4 of 228 (1.8%)	83 of 228 (36.4%)	0 of 228
CLS001 (Omiganan) Gel (Open-Label Period)	8 of 363 (2.2%)	116 of 363 (32%)	0 of 363

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.

41 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 41 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 41 sites in United States, Germany, France, United Kingdom, Australia 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 2 Aug 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?

Change in Inflammatory Lesion Count From Baseline to Week 12 (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 NCT02547441.

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.