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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
History of Changes
  Purpose

To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.


Condition Intervention Phase
Hygiene
 Drug: Cetylpyridinium chloride
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Patients will be evaluated according to the adverse reactions and the intensity of them. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: July 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cetylpyridinium chloride during 21 consecutive days.
 Drug: Cetylpyridinium chloride
Cetylpyridinium chloride during 21 consecutive days.

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729599

Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima, MD Sanofi-aventis administrative office Brazil
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00729599     History of Changes
Other Study ID Numbers: CPYRY_L_04020
Study First Received: August 4, 2008
Last Updated: March 3, 2009
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013