Acne VulgarisPhase 2NCT01326780
A Study of a New Drug Treatment for Acne
A Phase 2 study testing 1.2% JNJ 10229570-AAA, 2.4% JNJ 10229570-AAA and 3.6% JNJ 10229570-AAA in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 18 sites in United States.
Trial summary
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient. 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?
- 1.2% JNJ 10229570-AAA, 2.4% JNJ 10229570-AAA and 3.6% JNJ 10229570-AAA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 431 participants
- Where
- 18 sitesUnited States
- Study dates
- 31 Mar 2011to 31 Mar 2012
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
- If female of childbearing potential, must take a pregnancy test and have a negative result
- Females of childbearing potential must also agree to use an adequate method of birth control, which would include:
- systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)
- Condom with spermicide
- IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods
Who cannot join
- Known sensitivity to any of the ingredients in the study medication
- More than 3 nodulocystic acne lesions
- Use of acne treatments, therapies or medications within protocol-specified timeframes
- Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
- Excessive facial hair that may interfere with application of the medication and/or evaluations
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Northwestern University
Chicago, Illinois, 60611
Thomas J. Stephens & Associates, Inc.
Colorado Springs, Colorado, 80915
Research Across America
Dallas, Texas, 75234
Horizons Clinical Research Ctr., LLC
Denver, Colorado, 80220
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Penn State Medical Center
Hershey, Pennsylvania, 17033
Reliance Clinical Testing Services
Irving, Texas, 75062
North Florida Dermatology
Jacksonville, Florida, 32204
Dermatology Specialists Research, Inc
Louisville, Kentucky, 40202
Hilltop Research
Miamiville, Ohio, 45147
Wake Research Associates
Raleigh, North Carolina, 27612
TKL Research
Rochelle Park, New Jersey, 07662
University of California, San Diego
San Diego, California, 92093
University Clinical Trials, Inc.
San Diego, California, 92123
Gwinnett Clinical Research
Snellville, Georgia, 30078
Hilltop Research
St. Petersburg, Florida, 33710
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
About this study
Official title: A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.
Read the detailed description
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.
- Conditions
- Acne Vulgaris
- Being tested
- 1.2% JNJ 10229570-AAA, 2.4% JNJ 10229570-AAA, 3.6% JNJ 10229570-AAA, Vehicle control
- Keywords
- Acne, Irritation, Safety, Sebum
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.2% JNJ 10229570-AAADrug
Also called Not yet marketed
1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
2.4% JNJ 10229570-AAADrug
Also called Not yet marketed
2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
3.6% JNJ 10229570-AAADrug
Also called Not yet marketed
3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Vehicle controlOther
Also called Not marketed
Color matched cream vehicle, applied once daily to the face for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1.2% Facial Cream | Experimental | 1.2% JNJ 10229570-AAA Receives: Drug: 1.2% JNJ 10229570-AAA |
| 2.4% Facial Cream | Experimental | 2.4% JNJ 10229570-AAA Receives: Drug: 2.4% JNJ 10229570-AAA |
| 3.6% Facial Cream | Experimental | 3.6% JNJ 10229570-AAA Receives: Drug: 3.6% JNJ 10229570-AAA |
| 0% Facial Cream | Placebo comparator | Vehicle control Receives: Other: Vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Acne Lesion Counts
Change in lesion counts between baseline and end of study
Measured: Baseline to Week 12
Secondary outcomes (5)
Change From Baseline in the Non-inflammatory Acne Lesion Counts
Change in sum of open and closed comedones.
Measured: Baseline through Week 12
Change From Baseline in the Inflammatory Acne Lesion Counts
Change in sum of papules and pustules
Measured: Baseline through Week 12
Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)
Measured: Baseline through Week 12
Percent Change From Baseline in the Inflammatory Acne Lesion Counts
Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)
Measured: Baseline through Week 12
Percent Change From Baseline in Total Acne Lesion Counts
Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)
Measured: Baseline through Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study start31 Mar 2011
- Primary completion31 Mar 2012
- Study completion31 Mar 2012
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 Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326780
- Sponsor's protocol ID
- CA-P-8023
- Status last verified
- Oct 2019
- First submitted
- 30 Mar 2011
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01326780
- Acronym / sponsor ID
- CA-P-8023
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Irritation, Safety, Sebum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2011 (actual)
- Primary completion
- 31 Mar 2012 (actual)
- Study completion
- 31 Mar 2012 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.
Detailed description
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.2% Facial Cream | Experimental | Drug: 1.2% JNJ 10229570-AAA1.2% JNJ 10229570-AAA |
| 2.4% Facial Cream | Experimental | Drug: 2.4% JNJ 10229570-AAA2.4% JNJ 10229570-AAA |
| 3.6% Facial Cream | Experimental | Drug: 3.6% JNJ 10229570-AAA3.6% JNJ 10229570-AAA |
| 0% Facial Cream | Placebo comparator | Other: Vehicle controlVehicle control |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
- If female of childbearing potential, must take a pregnancy test and have a negative result
- Females of childbearing potential must also agree to use an adequate method of birth control, which would include:
Key exclusion criteria (5 listed)
- Known sensitivity to any of the ingredients in the study medication
- More than 3 nodulocystic acne lesions
- Use of acne treatments, therapies or medications within protocol-specified timeframes
- Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
- Excessive facial hair that may interfere with application of the medication and/or evaluations
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 |
|---|---|---|
| 1.2% JNJ 10229570-AAAAlso: Not yet marketed1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks | Drug | 1.2% Facial Cream |
| 2.4% JNJ 10229570-AAAAlso: Not yet marketed2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks | Drug | 2.4% Facial Cream |
| 3.6% JNJ 10229570-AAAAlso: Not yet marketed3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks | Drug | 3.6% Facial Cream |
| Vehicle controlAlso: Not marketedColor matched cream vehicle, applied once daily to the face for 12 weeks | Other | 0% Facial Cream |
Primary outcome
Change in Total Acne Lesion Counts
Time frame: Baseline to Week 12
Change in lesion counts between baseline and end of study
5 secondary outcomes
Change From Baseline in the Non-inflammatory Acne Lesion Counts
Time frame: Baseline through Week 12
Change From Baseline in the Inflammatory Acne Lesion Counts
Time frame: Baseline through Week 12
Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
Time frame: Baseline through Week 12
Percent Change From Baseline in the Inflammatory Acne Lesion Counts
Time frame: Baseline through Week 12
Percent Change From Baseline in Total Acne Lesion Counts
Time frame: Baseline through Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA's Drug FinderLink provided by the sponsor.
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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.
Johnson Varughese study director
Bausch Health Americas, Inc.
18 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 1.2% JNJ 10229570-AAA, 2.4% JNJ 10229570-AAA and 3.6% JNJ 10229570-AAA in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 18 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 6 inclusion and 5 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 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Yes. Results are posted in the registry (first posted 11 Dec 2018). 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 Total Acne Lesion Counts (time frame: Baseline to Week 12). 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 16 Oct 2019.