Papulopustular RosaceaPhase 2NCT01784133
A Twelve Week Safety and Efficacy Study in Rosacea
A Phase 2 study testing omiganan in people with Papulopustular Rosacea, run by Maruho Co., Ltd. at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with 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
- Papulopustular Rosacea
- What is being tested?
- omiganan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 17 sitesUnited States
- Study dates
- Mar 2013to Mar 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of papulopustular rosacea (at least 15 lesions)
Who cannot join
- nodular rosacea or subtype 3
- clinically significant abnormal findings that would interfere with study objectives
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Radiant Research Inc.
Birmingham, Alabama, 35209
Skin Care Research, Inc
Boca Raton, Florida, 33486
Dunedin Research Specialists
Dunedin, Florida, 34698
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
North Florida Dermatology Associates
Jacksonville, Florida, 32204
TriCities Skin and Cancer
Johnson City, Tennessee, 37674
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
The Savin Center, PC
New Haven, Connecticut, 06511
Virginia Clinical Research Inc.
Norfolk, Virginia, 23507
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Wake Resarch
Raleigh, North Carolina, 27612
Rochester General Medical Group Center for Dermatology at Linden Oaks
Rochester, New York, 14625
Dermatology Research Center
Salt Lake City, Utah, 84117
Progressive Clinical Research, PA
San Antonio, Texas, 78229
ATS Clinical Research
Santa Monica, California, 90404
Derm Research Center of NY Inc.
Stoney Brook, New York, 11790
Grekin Skin Institute
Warren, Michigan, 48088
About this study
Official title: A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
- Conditions
- Papulopustular Rosacea
- Being tested
- omiganan, placebo
- Keywords
- rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omigananDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| omiganan mid dose | Active comparator | omiganan mid dose once daily application for 12 weeks Receives: Drug: omiganan |
| omiganan high dose | Active comparator | omiganan high dose once daily application for 12 weeks Receives: Drug: omiganan |
| Vehicle group | Placebo comparator | Vehicle once daily application for 12 weeks Receives: Drug: placebo |
| omiganan low dose | Active comparator | omiganan low dose once daily application for 12 weeks Receives: Drug: omiganan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion count
Measured: 0, 1, 3, 6, 9 and 12 weeks
Secondary outcomes (1)
Success on IGA defined as clear or almost clear
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784133
- Sponsor's protocol ID
- CLS001-CO-PR-001
- Status last verified
- May 2015
- First submitted
- 1 Feb 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT01784133
- Acronym / sponsor ID
- CLS001-CO-PR-001
- Conditions
- Papulopustular Rosacea
- Keywords
- rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 5 Feb 2013 (estimated)
- 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.
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| omiganan mid dose | Active comparator | Drug: omigananomiganan mid dose once daily application for 12 weeks |
| omiganan high dose | Active comparator | Drug: omigananomiganan high dose once daily application for 12 weeks |
| Vehicle group | Placebo comparator | Drug: placeboVehicle once daily application for 12 weeks |
| omiganan low dose | Active comparator | Drug: omigananomiganan low dose once daily application for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of papulopustular rosacea (at least 15 lesions)
Key exclusion criteria (2 listed)
- nodular rosacea or subtype 3
- clinically significant abnormal findings that would interfere with study objectives
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 |
|---|---|---|
| omiganan | Drug | omiganan high dose, omiganan low dose, omiganan mid dose |
| placebo | Drug | Vehicle group |
Primary outcome
Change in inflammatory lesion count
Time frame: 0, 1, 3, 6, 9 and 12 weeks
1 secondary outcome
Success on IGA defined as clear or almost clear
Time frame: Week 12
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 20 May 2015.
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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.
17 sites 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 Papulopustular Rosacea, run by Maruho Co., Ltd. at 17 sites in United States.
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 1 inclusion and 2 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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?
Change in inflammatory lesion count (time frame: 0, 1, 3, 6, 9 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2015.