Acne VulgarisPhase 2NCT02066545
Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
A Phase 2 study testing CLS001 Topical Gel in people with Acne Vulgaris, run by Maruho Co., Ltd. at 20 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- CLS001 Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 20 sitesUnited States
- Study dates
- Apr 2014to Nov 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
- Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
- An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)
Who cannot join
- Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
- Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
- Subjects with more than 2 facial nodulocystic lesions
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Premier Research
Austin, Texas, 78705
Skin Care Research, Inc.
Boca Raton, Florida, 33486
J & S Studies, Inc.
College Station, Texas, 77845
Encino Research Center
Encino, California, 91436
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Consulting Services
High Point, North Carolina, 27262
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Manhattan Dermatology & Cosmetic Center
New York, New York, 10017
MedaPhase, Inc.
Newnan, Georgia, 30263
Belleair Research Center
Pinellas Park, Florida, 33781
Wake Research Associates
Raleigh, North Carolina, 27612
Progressive Clinical Research, PA
San Antonio, Texas, 78229
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Clinical Science Institute
Santa Monica, California, 90404
Premier Clinical Research
Spokane, Washington, 99204
Derm Research Center of New York, Inc.
Stony Brook, New York, 11790
Moore Clinical Research, Inc.
Tampa, Florida, 33609
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, 33401
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 Acne Vulgaris
The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- CLS001 Topical Gel, CLS001 Topical Gel Vehicle
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLS001 Topical GelDrug
CLS001 Topical Gel VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Gel | Placebo comparator | Not described Receives: Drug: CLS001 Topical Gel Vehicle |
| CLS001 topical gel 1% | Experimental | Topical application once daily Receives: Drug: CLS001 Topical Gel |
| CLS001 topical gel 1.75% | Experimental | Topical application once daily Receives: Drug: CLS001 Topical Gel |
| CLS001 topical gel 2.5% | Experimental | Topical application once daily Receives: Drug: CLS001 Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion count from Baseline
Measured: 6, 9 and 12 weeks
Secondary outcomes (4)
Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions
Measured: 1, 3, 6, 9 and 12 weeks
Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions
Measured: 1, 3, 6, 9 and 12 weeks
Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit
Measured: 1, 3, 6, 9, and 12 weeks
Percentage of subjects with a 2 grade reduction in the IGA at each visit
Measured: 1, 3, 6, 9, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
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
- 327 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
- NCT02066545
- Sponsor's protocol ID
- CLS001-CO-PR-003
- Status last verified
- Sep 2015
- First submitted
- 18 Feb 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 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 Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02066545
- Acronym / sponsor ID
- CLS001-CO-PR-003
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- First posted
- 19 Feb 2014 (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 once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vehicle Gel | Placebo comparator | Drug: CLS001 Topical Gel Vehicle |
| CLS001 topical gel 1% | Experimental | Drug: CLS001 Topical GelTopical application once daily |
| CLS001 topical gel 1.75% | Experimental | Drug: CLS001 Topical GelTopical application once daily |
| CLS001 topical gel 2.5% | Experimental | Drug: CLS001 Topical GelTopical application once daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
- Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
- An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)
Key exclusion criteria (3 listed)
- Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
- Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
- Subjects with more than 2 facial nodulocystic lesions
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 Topical Gel | Drug | CLS001 topical gel 1%, CLS001 topical gel 1.75%, CLS001 topical gel 2.5% |
| CLS001 Topical Gel Vehicle | Drug | Vehicle Gel |
Primary outcome
Change in inflammatory lesion count from Baseline
Time frame: 6, 9 and 12 weeks
4 secondary outcomes
Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions
Time frame: 1, 3, 6, 9 and 12 weeks
Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions
Time frame: 1, 3, 6, 9 and 12 weeks
Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit
Time frame: 1, 3, 6, 9, and 12 weeks
Percentage of subjects with a 2 grade reduction in the IGA at each visit
Time frame: 1, 3, 6, 9, and 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 17 Sep 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.
20 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 CLS001 Topical Gel in people with Acne Vulgaris, run by Maruho Co., Ltd. at 20 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 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 from Baseline (time frame: 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 17 Sep 2015.