Acne VulgarisPhase 4NCT00377000
A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.
A Phase 4 study testing clindamycin 1% / benzoyl peroxide 5% gel pump and clindamycin 1% / benzoyl peroxide 5% tube in people with Acne Vulgaris, run by Sanofi.
Trial summary
Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- clindamycin 1% / benzoyl peroxide 5% gel pump and clindamycin 1% / benzoyl peroxide 5% tube
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Mar 2006
- Phase
- Phase 4
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with a clinical diagnosis of acne vulgaris of mild to moderate severity
- Females of childbearing potential, in addition to having a negative urine pregnancy test at Visit 1, must be willing to use an acceptable form of birth control during the study.
- Patients 18 years of age or older must provide Institutional Review Board (IRB) approved written informed consent. Patients under 18 years of age must have IRB approved written informed consent from a parent or legal guardian. Patients 12 - 17 years of age must complete an IRB approved assent form for minors.
- Patients must be willing and able to understand the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
- Patients must be in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
- Patients who use make-up must have used the same brand of make-up for a minimum period of 2 weeks prior to Baseline and agree to not change make-up brands or types during the study.
Who cannot join
- Patients who are pregnant, nursing, or planning a pregnancy within the study period.
- Patients who have more than 2 nodulo-cystic lesions on the face, excluding the nose.
- Patients who have a known hypersensitivity to any ingredients in the test products including clindamycin and benzoyl peroxide.
- Patients who have been treated with prescription and/or over-the-counter topical products, or had a procedure performed that may impact study assessments.
- Patients who have any systemic or dermatological disorder that has the potential to interfere with the evaluations (e.g., rosacea, seborrheic dermatitis, perioral dermatitis, corticosteroid-induced acne vulgaris, carcinoid syndrome, mastocytosis, acneform eruptions caused by medication, facial psoriasis, facial eczema, etc.).
- Patients with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
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- Patients who engage in activities that involve excessive or prolonged exposure to sunlight.
- Patients who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with this protocol.
- Patients who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry.
- Alcoholic toners, astringents, medicated topical preparations (prescriptions and over-the-counter), or medicated make-up on the facial treatment area.
- Abrasive cleansers or washes to the facial area.
- New cosmetics, or new cleansers applied to the face.
- Patients must not wear make-up at the visits, so as not to interfere with the evaluations.
- Patients should not use a sauna within 48 hours prior to each visit.
About this study
Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation.
- Conditions
- Acne Vulgaris
- Being tested
- clindamycin 1% / benzoyl peroxide 5% gel pump, clindamycin 1% / benzoyl peroxide 5% tube
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clindamycin 1% / benzoyl peroxide 5% gel pumpDrug
clindamycin 1% / benzoyl peroxide 5% tubeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference Questionnaire evaluation: including product use, patient knowledge and impression of acne, as well as patient treatment
The incidence of all adverse events reported during the study will be summarized by treatment group
The signs and symptoms of irritation will be summarized descriptively by treatment group at every visit
Investigator irritation grading - erythema, peeling, dryness and pruritus at Baseline (Week 0), Week 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startNov 2005
- Study completionMar 2006
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.
- More trials run by SanofiThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Phyllis Diener, MT, ASCP, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377000
- Sponsor's protocol ID
- DL6021-0505
- Status last verified
- Oct 2007
- First submitted
- 14 Sep 2006
- Last updated
- 10 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.
- ClinicalTrials.gov ID
- NCT00377000
- Acronym / sponsor ID
- DL6021-0505
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Mar 2006
- First posted
- 15 Sep 2006 (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.
Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with a clinical diagnosis of acne vulgaris of mild to moderate severity
- Females of childbearing potential, in addition to having a negative urine pregnancy test at Visit 1, must be willing to use an acceptable form of birth control during the study.
- Patients 18 years of age or older must provide Institutional Review Board (IRB) approved written informed consent. Patients under 18 years of age must have IRB approved written informed consent from a parent or legal guardian. Patients 12 - 17 years of age must complete an IRB approved assent form for minors.
- Patients must be willing and able to understand the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
- Patients must be in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
Key exclusion criteria (14 listed)
- Patients who are pregnant, nursing, or planning a pregnancy within the study period.
- Patients who have more than 2 nodulo-cystic lesions on the face, excluding the nose.
- Patients who have a known hypersensitivity to any ingredients in the test products including clindamycin and benzoyl peroxide.
- Patients who have been treated with prescription and/or over-the-counter topical products, or had a procedure performed that may impact study assessments.
- Patients who have any systemic or dermatological disorder that has the potential to interfere with the evaluations (e.g., rosacea, seborrheic dermatitis, perioral dermatitis, corticosteroid-induced acne vulgaris, carcinoid syndrome, mastocytosis, acneform eruptions caused by medication, facial psoriasis, facial eczema, etc.).
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 |
|---|---|---|
| clindamycin 1% / benzoyl peroxide 5% gel pump | Drug | – |
| clindamycin 1% / benzoyl peroxide 5% tube | Drug | – |
Primary outcome
Patient Preference Questionnaire evaluation: including product use, patient knowledge and impression of acne, as well as patient treatment
The incidence of all adverse events reported during the study will be summarized by treatment group
The signs and symptoms of irritation will be summarized descriptively by treatment group at every visit
Investigator irritation grading - erythema, peeling, dryness and pruritus at Baseline (Week 0), Week 2, 4, and 6
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 10 Oct 2007.
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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.
Phyllis Diener, MT, ASCP study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clindamycin 1% / benzoyl peroxide 5% gel pump and clindamycin 1% / benzoyl peroxide 5% tube in people with Acne Vulgaris, run by Sanofi.
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 14 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 10 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient Preference Questionnaire evaluation: including product use, patient knowledge and impression of acne, as well as patient treatment. The study lists 4 primary outcomes in all. 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 10 Oct 2007.