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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dermatologic Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014