Acne VulgarisPhase 2NCT02571998
A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
A Phase 2 study testing Omiganan (CLS001) Topical Gel in people with Acne Vulgaris, run by Maruho Co., Ltd. at 29 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Omiganan (CLS001) Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 29 sitesUnited States
- Study dates
- Oct 2015to Aug 2016
- 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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
- Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
- Subjects with ≥ 30 facial inflammatory lesions
Who cannot join
- Subjects with < 10 or > 75 facial non-inflammatory lesions
- Subjects with > 3 facial nodular or cystic lesions at Baseline
- Standard exclusion criteria
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Albuquerque, New Mexico
Study site
Arlington, Texas
Study site
Austin, Texas
Study site
Beverly, Massachusetts
Study site
Boca Raton, Florida
Study site
Boynton Beach, Florida
Study site
Denver, Colorado
Study site
Fort Gratiot, Michigan
Study site
High Point, North Carolina
Study site
Knoxville, Tennessee
Study site
Las Vegas, Nevada
Study site
Miami, Florida
Study site
Mobile, Alabama
Study site
New York, New York
Study site
Newington, New Hampshire
Study site
Pflugerville, Texas
Study site
Phoenix, Arizona
Study site
Pinellas Park, Florida
Study site
Raleigh, North Carolina
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Sanford, Florida
Study site
Santa Ana, California
Study site
Santa Monica, California
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
Stony Brook, New York
Study site
Tampa, Florida
Study site
Webster, Texas
About this study
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris
The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Omiganan (CLS001) Topical Gel, Vehicle Topical Gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omiganan (CLS001) Topical GelDrug
Vehicle Topical GelDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Omiganan (CLS001) Topical Gel applied once daily Receives: Drug: Omiganan (CLS001) Topical Gel |
| Vehicle Gel | Placebo comparator | Vehicle Topical Gel applied once daily Receives: Drug: Vehicle Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in inflammatory lesion counts at week 12
Measured: 12 weeks
Secondary outcomes (4)
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions
Measured: 12 weeks
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit
Measured: 12 weeks
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit
Measured: 12 weeks
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 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
- NCT02571998
- Sponsor's protocol ID
- CLS001-CO-PR-009
- Status last verified
- Mar 2017
- First submitted
- 2 Oct 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02571998
- Acronym / sponsor ID
- CLS001-CO-PR-009
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Oct 2015 (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 primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
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: Omiganan (CLS001) Topical GelOmiganan (CLS001) Topical Gel applied once daily |
| Vehicle Gel | Placebo comparator | Drug: Vehicle Topical GelVehicle Topical Gel applied once daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
- Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
- Subjects with ≥ 30 facial inflammatory lesions
Key exclusion criteria (3 listed)
- Subjects with < 10 or > 75 facial non-inflammatory lesions
- Subjects with > 3 facial nodular or cystic lesions at Baseline
- 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 |
|---|---|---|
| Omiganan (CLS001) Topical Gel | Drug | Treatment |
| Vehicle Topical Gel | Drug | Vehicle Gel |
Primary outcome
Absolute change from baseline in inflammatory lesion counts at week 12
Time frame: 12 weeks
4 secondary outcomes
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions
Time frame: 12 weeks
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit
Time frame: 12 weeks
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit
Time frame: 12 weeks
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.
Time frame: 12 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 Mar 2017.
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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.
29 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 (CLS001) Topical Gel in people with Acne Vulgaris, run by Maruho Co., Ltd. at 29 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 3 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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?
Absolute change from baseline in inflammatory lesion counts at week 12 (time frame: 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 27 Mar 2017.