Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00729599
First received: August 4, 2008
Last updated: March 3, 2009
Last verified: March 2009

August 4, 2008
March 3, 2009
July 2008
August 2008   (final data collection date for primary outcome measure)
Patients will be evaluated according to the adverse reactions and the intensity of them. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00729599 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hygiene
Drug: Cetylpyridinium chloride
Cetylpyridinium chloride during 21 consecutive days.
Experimental: 1
Cetylpyridinium chloride during 21 consecutive days.
Intervention: Drug: Cetylpyridinium chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Not Provided
August 2008   (final data collection date for primary outcome measure)

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;
Both
10 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00729599
CPYRY_L_04020
No
Medical Affairs Study Director, Sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima, MD Sanofi-aventis administrative office Brazil
Sanofi
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP