Acne VulgarisPhase 4NCT00907257
A Study of Different Use Regimens Using Two Acne Treatments
A Phase 4 study testing benzoyl peroxide wash and Tretinoin gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 12 sites in United States.
Trial summary
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening. 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?
- benzoyl peroxide wash and Tretinoin gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2009to Sep 2009
- Phase
- Phase 4
- 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
- Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
- Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
- Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
- Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline
Who cannot join
- Known sensitivity to any of the ingredients in the study medication;
- Any nodulocystic acne lesions;
- Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;
- Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;
- Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;
- Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study;
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- If subject is taking birth control pills, she must be stabilized for at least three months prior to study start;
- History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication;
- Any significant medical conditions that could confound the interpretation of the study;
- Excessive facial hair that may interfere with evaluations;
- No use of tanning booths, sun lamps, etc.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
Skin Care Research, Inc.
Boca Raton, Florida, 33486
Dermatology Research Associates
Cincinnatti, Ohio, 45230
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Derm Research, PLLC
Louisville, Kentucky, 40217
Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
International Dermatology Research, Inc.
Miami, Florida, 33144
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Gwinnett Clinical Research
Snellville, Georgia, 30078
DermResearch Center of New York
Stony Brook, New York, 11790
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
About this study
Official title: A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
Read the detailed description
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.
- Conditions
- Acne Vulgaris
- Being tested
- benzoyl peroxide wash, Tretinoin gel
- Keywords
- acne, irritation, objective sensory methods
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzoyl peroxide washDrug
Also called OXY Wash
5% benzoyl peroxide wash
Tretinoin gelDrug
Also called Retin-A Micro Pump
0.04% tretinoin gel
| Study group | Role | What they receive |
|---|---|---|
| Same time of day | Experimental | 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day Receives: Drug: benzoyl peroxide wash; Drug: Tretinoin gel |
| Different times of day | Active comparator | 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening Receives: Drug: benzoyl peroxide wash; Drug: Tretinoin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Facial Acne Lesion Count
Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.
Measured: Baseline to Week 12
Secondary outcomes (2)
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).
Measured: Baseline to Week 12
Measurement of Success
Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:
0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionSep 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Rossi, MD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907257
- Sponsor's protocol ID
- CA-P-6270
- Status last verified
- Feb 2012
- First submitted
- 20 May 2009
- Last updated
- 15 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.
PubMed 20677537
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00907257
- Acronym / sponsor ID
- CA-P-6270
- Conditions
- Acne Vulgaris
- Keywords
- acne, irritation, objective sensory methods
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Posted 21 Jan 2011
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 using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
Detailed description
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same time of day | Experimental | Drug: benzoyl peroxide wash, Drug: Tretinoin gel5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day |
| Different times of day | Active comparator | Drug: benzoyl peroxide wash, Drug: Tretinoin gel5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris;
- Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);
- Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones);
- Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline
Key exclusion criteria (11 listed)
- Known sensitivity to any of the ingredients in the study medication;
- Any nodulocystic acne lesions;
- Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study;
- Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study;
- Topical use of retinoids within two weeks prior to study start and throughout the duration of the study;
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 |
|---|---|---|
| benzoyl peroxide washAlso: OXY Wash5% benzoyl peroxide wash | Drug | Different times of day, Same time of day |
| Tretinoin gelAlso: Retin-A Micro Pump0.04% tretinoin gel | Drug | Different times of day, Same time of day |
Primary outcome
Change From Baseline in Total Facial Acne Lesion Count
Time frame: Baseline to Week 12
Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.
2 secondary outcomes
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
Time frame: Baseline to Week 12
Measurement of Success
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20677537Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.
- 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.
Ana Rossi, MD study director
Johnson & Johnson Consumer and Personal Products Worldwide
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing benzoyl peroxide wash and Tretinoin gel in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 12 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 4 inclusion and 11 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 21 Jan 2011). 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 From Baseline in Total Facial Acne Lesion Count (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?
On the ClinicalTrials.gov record for NCT00907257, which also lists 1 linked publication.
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 15 Feb 2012.