HygienePhase 3Cepacol TeenNCT00729599
Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.
A Phase 3 study testing Cetylpyridinium chloride in people with Hygiene, run by Sanofi at 1 site in Brazil.
Trial summary
To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hygiene
- What is being tested?
- Cetylpyridinium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Aug 2008
- Phase
- Phase 3
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Integral buccal mucous (without oral pathologies);
- Normal odontological exams;
Who cannot join
- Lactation or gestational risk or gestation;
- Use of Antiinflammatory or immunosuppression drugs 15 days before the study;
- Being in odontological treatment;
- Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
- Personal history of allergic disease in the area to be treated;
- Allergic or atopic history;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.
To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.
- Conditions
- Hygiene
- Being tested
- Cetylpyridinium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetylpyridinium chlorideDrug
Cetylpyridinium chloride during 21 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cetylpyridinium chloride during 21 consecutive days. Receives: Drug: Cetylpyridinium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients will be evaluated according to the adverse reactions and the intensity of them.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HygieneStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaderson Lima, MD, Study director, Sanofi-aventis administrative office Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729599
- Sponsor's protocol ID
- CPYRY_L_04020
- Acronym
- Cepacol Teen
- Status last verified
- Mar 2009
- First submitted
- 4 Aug 2008
- Last updated
- 4 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.
- ClinicalTrials.gov ID
- NCT00729599
- Acronym / sponsor ID
- Cepacol Teen / CPYRY_L_04020
- Conditions
- Hygiene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 7 Aug 2008 (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.
To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cetylpyridinium chlorideCetylpyridinium chloride during 21 consecutive days. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Integral buccal mucous (without oral pathologies);
- Normal odontological exams;
Key exclusion criteria (6 listed)
- Lactation or gestational risk or gestation;
- Use of Antiinflammatory or immunosuppression drugs 15 days before the study;
- Being in odontological treatment;
- Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
- Personal history of allergic disease in the area to be treated;
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 |
|---|---|---|
| Cetylpyridinium chlorideCetylpyridinium chloride during 21 consecutive days. | Drug | 1 |
Primary outcome
Patients will be evaluated according to the adverse reactions and the intensity of them.
Time frame: 21 days
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 4 Mar 2009.
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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.
Jaderson Lima, MD study director
Sanofi-aventis administrative office Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetylpyridinium chloride in people with Hygiene, run by Sanofi at 1 site in Brazil.
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 2 inclusion and 6 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 4 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Patients will be evaluated according to the adverse reactions and the intensity of them. (time frame: 21 days). 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 4 Mar 2009.