Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hygiene
Intervention: Cetylpyridinium chloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Jaderson Lima, MD, Study Director, Affiliation: Sanofi-aventis administrative office Brazil
Summary
To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to
odontological usage.
Clinical Details
Official title: Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Patients will be evaluated according to the adverse reactions and the intensity of them.
Eligibility
Minimum age: 10 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Integral buccal mucous (without oral pathologies);
- Normal odontological exams;
Exclusion Criteria:
- 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;
Locations and Contacts
Sanofi-aventis, São Paulo, Brazil
Additional Information
Starting date: July 2008
Last updated: March 3, 2009
|